HEALTH FOR THE 21

AGENDA FOR RESEARCH ON WOMEN’S

ST CENTURY ff O ci e of Research on women's Health

National Institutes of Health

NAOF Of

AGENDA FOR RESEARCH

ON WOMEN’S HEALTH

FOR THE 21ST CENTURY

A Report of the Task Force on the

NIH Women’s Health Research Agenda 

for the 21st Century

NATIONAL INSTITUTES 

OF HEALTH

Office of the Director

Office of Research 

on Women’s Health

VOLUME 2
U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health. 

Agenda for Research on Women’s Health for the 21st Century. A Report of the Task Force on the 

NIH Women’s Health Research Agenda for the 21st Century, Volume 2. Bethesda, MD. 

NIH Publication No. 99-4386. 1999.
THE SECRETARY OF HEALTH AND HUMAN SERVICES

WASHINGTON, DC

SEP 25 1996

MESSAGE TO THE PARTICIPANTS AT THE MEETING BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH FOR THE 21ST CENTURY

I wanted to be with you today for this first regional meeting to update the current 

biomedical and behavioral research agenda on women’s health. You have my best 

wishes for a productive and fruitful exchange of ideas.

The agencies of the Department of Health and Human Services share the common goal 

of improving the health of all citizens. And research on women’s health is an important

priority for this Department and for the agencies of the Public Health Service, including

the National Institutes of Health (NIH).

The NIH, through its Office of Research on Women’s Health (ORWH), under the very

capable leadership of Dr. Vivian Pinn, spearheads the effort to accomplish this goal

through research. By continually identifying emerging needs for scientific knowledge, 

the ORWH and the NIH are insuring that the agenda on women’s health research 

remains viable and relevant to the health needs of women in the 21st century.

The multidisciplinary approaches and perspectives represented at this meeting will 

greatly enhance the ability of the Department to broaden its research agenda. I look 

forward to learning about your deliberations.

My best wishes.

Donna E. Shalala

VOLUME 2

FOREWORD

On the brink of the new century, we face the exciting and unprecedented opportunity to understand

the functioning of our bodies and our minds to an extent that could not have been envisioned 100,

or even 50, years ago. Along with a rapid pace of scientific discovery, the issue of women’s health 

has risen to prominence over the past decade, in the broadest biomedical, political, and social sense. Our Nation

has recognized the importance of women’s health, and more specifically, the role that culture, ethnicity, race,

socioeconomic background, geographic location, and other social and economic factors have as important contributors to women’s health status. We now understand women’s health as a reflection of multiple elements 

contributing to the overall quality of women’s lives — and men’s lives — in the United States today. 

After a year of intensive planning, the dream of a coordinated effort on women’s health at the National 

Institutes of Health became a much-anticipated reality in September 1991 at a conference and series of workshops in Hunt Valley, Maryland. Experts in the fields of basic and clinical sciences, practitioners interested in

women’s health, and representatives of women’s organizations developed specific and workable recommendations to advance research activities on behalf of all the women, and thus of all the people, of the United States. 

Participants focused on research needs over the major divisions of a woman’s life span and the scientific issues, 

diseases, and impairments that might affect her health and well being during that life span. The deliberations 

and findings, published as Opportunities for Research on Women’s Health, stated a firm expectation as part 

of the Introduction: “This research agenda, which will guide planning efforts at the NIH for the next several

decades, is critical to improving the quality of life for all the Nation’s women.” That report became the firm 

foundation and touchstone for the work of the Office of Research on Women’s Health under its permanent 

director, Dr. Vivian Pinn, whose appointment was announced at the September 1991 meeting.

Over the past 7 years, the Office of Research on Women’s Health at the National Institutes of Health has

moved steadily and with confidence toward achieving the far-reaching goals articulated in 1991. The Office 

has identified and assessed the enormous advances in basic and clinical science knowledge and linked them 

to a research agenda targeted to improve women’s health. There is now widespread, and largely unquestioned,

recognition that researchers and clinicians must understand how differences in sex, gender, cultural, and ethnic

and socioeconomic backgrounds may influence the causes, diagnoses, progression, and treatment of diseases. 

v
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

The evolution, or perhaps even more, revolution in activities related to women’s health, made the need for a

reassessment of the agenda critical. An intensive series of workshops and meetings, culminating in this new 

report, “Agenda for Research on Women’s Health for the 21st Century,” extend the vision of a comprehensive

women’s health research agenda into exciting new directions and areas of research endeavor not anticipated in

1991. The new challenge inherent to continuing progress in research on women’s health is to establish sound 

scientific bases that will permit reliable diagnoses and effective prevention and treatment strategies for all women,

from diverse cultural and ethnic origins, geographic locations, and socioeconomic strata. The ultimate goal is to

increase medical knowledge through sound research, which, thereby, will inform the development of policies 

and medical standards from which all women, and men, can benefit equally.

But, it is clear that the guiding principle regarding women’s health research at the National Institutes of 

Health must remain and has remained unchanged from its original ideal: that biomedical research must be 

targeted to all of the Nation’s women, of all races, all ages, and all socioeconomic and ethnic groups. Researchers

must continue to make more intensive efforts to address the health needs of the whole woman — in body and in

mind. As citizens of the United States and of the world, we cannot afford to do anything less.

Ruth L. Kirschstein, M.D.

Deputy Director, National Institutes of Health

Former Director, National Institute of General Medical

Sciences (1974-1993) and Acting Associate Director,

Office of Research on Women’s Health (1990-1991)
Message from The Secretary of Health and Human Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Donna E. Shalala 

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

Ruth L. Kirschstein, M.D. 

Motion passed by the Advisory Committee on Research on Women’s Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

Vivian W. Pinn, M.D.

Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Vivian W. Pinn, M.D.

Overview and Perspective of the Task Force Cochairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Marianne Legato, M.D., F.A.C.P.; Donna Dean, Ph.D.

The Use of “Sex” and “Gender” to Define and Characterize Meaningful Differences 

Between Men and Women . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Jennifer R. Fishman, B.A.; Janis G. Wick, M.A.; Barbara A. Koenig, Ph.D. 

Scientific Chapters

Alcohol, Tobacco, and Other Drug Use, Disorders, and Consequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Mary Dufour, M.D., M.P.H.; Mary McCaul, Ph.D.; Cora Lee Wetherington, Ph.D.; Sharon Wilsnack, Ph.D.; 

Catherine Bolek, M.S.

Behavioral and Social Sciences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Virginia S. Cain, Ph.D.; Karen Scott Collins, M.D., M.P.H.; Susan Baird Kanaan 

Bone and Musculoskeletal Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Joan A. McGowan, Ph.D.; Laura Lowe Tosi, M.D.; Barbara Drinkwater, Ph.D.; Joanna Taylor

Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Edward Trimble, M.D., M.P.H.; Karen Antman, M.D.; Jean Sevin, Ph.D. 

Cardiovascular Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

David Robinson, Ph.D.; Judith LaRosa, Ph.D., R.N., F.A.A.N.; Nanette K. Wenger, M.D.; 

Anne Brown Rodgers 

Digestive Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

James E. Everhart, M.D., M.P.H.; Joanne A.P. Wilson, M.D., F.A.C.P.; Jacqueline Wolf, M.D.; 

Joanne B. Brodsky

Immunity and Autoimmune Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Elaine Collier, M.D.; Betty Diamond, M.D.; Anita Corman Weinblatt, Ph.D.; 

Caroline Whitacre, Ph.D.; Kimberly C. Mitchell, M.P.H.

Infectious Diseases and Emerging Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Sharilyn K. Stanley, M.D.; Howard Minkoff, M.D.; Donna Savage, M.Ed.

Mental Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Delores L. Parron, Ph.D.; M. Katherine Shear, M.D.; Donna R. Savage, M.Ed.

Neuroscience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Constance W. Atwell, Ph.D.; Howard Kurtzman, Ph.D.; Bruce S. McEwen, Ph.D.; 

Barbara P. Ordway

Oral Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Maryann Redford, D.D.S., M.P.H.; Marjorie Jeffcoat, D.M.D.; Susan Silverton, M.D., Ph.D.; 

Joanna Fringer, M.A.

C O NTENTS
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Pharmacologic Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Mary J. Berg, Pharm.D.; Jeanne N. Ketley, Ph.D.; Ruth Merkatz, Ph.D.; Abraham Mittelman, M.P.H. 

Reproductive Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Florence P. Haseltine, M.D., Ph.D.; Gloria Sarto, M.D., Ph.D.; Wulf A. Utian, M.D., Ph.D.; 

Donna L. Vogel, M.D., Ph.D.; Cheryl Campbell; Rafaela-Socorro Roncal, M.D.

Urologic and Kidney Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Deborah Erickson, M.D.; Leroy M. Nyberg, M.D., Ph.D.; Ebrahim E. Versi, M.D., Ph.D.; Verna Hillsamer, M.S.

Career Issues for Women Scientists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Catherine Didion; Joan Y. Reede, M.D.; Joan P. Schwartz, Ph.D.; Eleanor G. Shore, M.D., M.P.H.; Roxanne Smith

Selected Issues in Research Design 

Health of Special Populations of Women . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

Gloria E. Sarto, M.D., Ph.D.

Sex and Gender Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

George W. Counts, M.D.; Otis Brawley, M.D.; Rosalie Sagraves, Pharm.D.; Carollyne Hutter 

Racial, Ethnic, and Cultural Diversity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

Virginia Cain, Ph.D.; Helen Rodriguez-Trias, M.D.; Wanda Avila

Multidisciplinary Perspectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

Patricia Grady, Ph.D., R.N.; Brian Strom, M.D., M.P.H.; Susan Farer

Selected Topics in Health Impact AND Health Outcomes

Selected Topics in Health Impact and Health Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

Judy Norsigian; Maria Freire, Ph.D.; Debra Powell; Mary J. Berg, Pharm.D.; Jeanne N. Ketley, Ph.D.; Ruth Merkatz, Ph.D.

Presentations at Bethesda National Meeting 

Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245

The Honorable Barbara A. Mikulski, M.S.W., U.S. Senate

Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248

The Honorable Constance A. Morella, M.A., U.S. House of Representatives

Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

The Honorable Louise M. Slaughter, M.S., U.S. House of Representatives

Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253

The Honorable Louis Stokes, J.D., U.S. House of Representatives

Presented by Fredette West

Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255

Audrey T. Haynes, M.S.W., The White House

Genetics, Genomics, and Women’s Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256

Francis Collins, M.D., Ph.D. 

Social, Legal, and Ethical Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263

Karen Rothenberg, J.D., M.P.A.

Social and Ethical Priorities for Women’s Health Research and Human Genetics . . . . . . . . . . . . . . . . . . . . . . . . . . . 265

John Fletcher, Ph.D.

Legal and Ethical Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271

Robert F. Murray, Jr., M.D.

Heart Disease Research in Women: A Look Back and a View to the Future . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272

Claude Lenfant, M.D.

Research on Women: An Investigator’s View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276

Julie Buring, Sc.D. 

The Cancer Program at the End of the 20th Century . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279

Richard Klausner, M.D.

Women and Research: Quo Vadis? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285

Antonia C. Novello, M.D., M.P.H.

Beyond Hunt Valley: Perspectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292

Maureen Henderson, M.D., Dr.P.H.
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VOLUME 2

Implications for Education and Public Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294

Barbara Ross-Lee, D.O.

Women in Biomedical Careers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297

Lydia Villa-Komaroff, Ph.D. 

Women and Health: Time for a New Paradigm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300

Margaret A. Chesney, Ph.D.

Putting It All Together . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301

Byllye Avery, M.Ed.

Public Testimony

Introduction to the Public Testimony . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307

Vivian W. Pinn, M.D.

Summaries of Public Testimony at Philadelphia Regional Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 309

Summaries of Public Testimony at New Orleans Regional Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 335

Summaries of Public Testimony at Santa Fe Regional Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 355

Summaries of Public Testimony at Bethesda National Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 407

Appendix

Workshop Agendas and Participants

Philadelphia Regional Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 473

New Orleans Regional Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 489

Santa Fe Regional Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 499

Bethesda National Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 513

INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543

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VOLUME 2

“beyond Hunt Valley.” Not only have many of the 

special concerns of girls and women been studied

since the first research agenda was constituted through

the Office of Research on Women’s Health, but girls

and women are no longer being automatically treated

as a monolithic group now that the research focus 

is increasingly mindful of the interface between the

behavioral and the biomedical sciences. This growing

awareness of the complexities of human experience

bodes well for better understanding of the human

experience in the 21st century.

We move that the Advisory Committee accept 

this report, commend those people involved, recommend broad dissemination of the report and that this

process be repeated five years from now in 2004.

The motion was passed unanimously.

Dyanne D. Affonso, Ph.D., F.A.A.N.

Katherine L. Alley, M.D.

Karen H. Antman, M.D.

Byllye Y. Avery, M.Ed.

Mary J. Berg, Pharm.D.

David M. Brown, M.D.

George T. Bryan, M.D.

Linda Burhansstipanov, M.S.P.H., Dr.P.H.

John J. Estrada, M.D.

Irma E. Goertzen

Joseph K. Hurd, M.D.

Barbara A. Koenig, Ph.D.

Marianne J. Legato, M.D., F.A.C.P.

Angela Barron McBride, Ph.D., R.N., F.A.A.N.

Linda C. Niessen, D.M.D., M.P.H.

Suzanne Oparil, M.D.

Amelie G. Ramirez, Dr.P.H.

Nancy Sabin Wexler, Ph.D.

Nancy A. Fugate Woods, Ph.D., R.N., F.A.A.N.

National Institutes of Health

November 16, 1998

MOTION

Taking seriously the strategic planning charge to

the Office of Research on Women’s Health (ORWH) 

in the National Institutes of Health Revitalization 

Act, this report entitled, Agenda for Research on

Women’s Health for the 21st Century summarizes

progress to date and research challenges for the next

millennium. The Advisory Committee to the Office 

of Research on Women’s Health strongly recommends

acceptance of this report.

The Advisory Committee commends: Dr. Vivian

Pinn for the all inclusive and collegial approach to 

data gathering that shaped this project; Ms. Joyce

Rudick for her people-oriented administrative abilities; Dr. Donna Dean and Dr. Marianne Legato, Task

Force Cochairs, who demonstrated in their vision 

and organization just how creative and comprehensive collaboration between the National Institutes 

of Health and the academic community can be; the

Task Force on the NIH Women’s Health Research

Agenda for the 21st Century for recognizing that 

a national agenda must be mindful of regional concerns; and the more than 1,500 women and men 

who participated in the public hearings and scientific workshops for ensuring that the community 

at large was front and center in this process.

The Advisory Committee also recommends broad

dissemination of this report, implementation of the

regent with the collaboration of the NIH Institutes 

and Centers, and encourages Dr. Harold Varmus to

support the Office of Research on Women’s Health in

this endeavor, particularly in the work of moving the

research agenda forward within the National Institutes

of Health. The Advisory Committee recognizes that

women’s health research has substantially gone

MOTION PASSED BY THE ADVISORY 

C O MMITTEE ON RESEARCH ON 

WOMEN’S HEALTH

During 1996 and 1997, the Office of Research on Women’s Health (ORWH) of the National Institutes 

of Health (NIH), with the assistance of the Task Force on the NIH Women’s Health Research Agenda

for the 21st Century (Task Force) and the NIH Advisory Committee on Research on Women’s Health

(ACRWH), convened a series of three meetings at regional sites across the country and a final, national meeting to

review the NIH’s scientific agenda for research on women’s health issues. This series of meetings provided a forum

during which more than 1,500 scientists, clinicians, public policy makers, advocates, and members of the general

public examined the state of women’s health research at this point in history and discussed areas of emerging

importance for women’s health and biomedical research in order to develop a revised agenda that will address 

the changing public health and scientific needs and opportunities of the 21st Century.

We are grateful to all who participated in these meetings and shared their knowledge, insights, concerns, 

and commitment to improving the health of women through the formulation of a coherent and comprehensive

agenda of basic and clinical biomedical and behavioral research. The recommendations made by participants at 

the four meetings will enable NIH to continue to foster and sustain multidisciplinary studies that address health

and disease in girls and women across the life span.

This series of meetings would not have been possible without the assistance of a great many individuals,

including Ms. Joyce Rudick, the Acting Deputy Director of ORWH, who worked tirelessly in the planning, 

development, and organization of these meetings to review the NIH’s agenda for research on women’s health. 

In this process, NIH has benefitted particularly from the contributions made by members of the NIH scientific

community and by the Task Force on the NIH Women’s Health Research Agenda for the 21st Century. ORWH 

has been fortunate to have representatives of the NIH community, as well as women’s health advocates, scientists,

and health professionals from across the country serve as members of this important Task Force. We owe a 

special debt of gratitude to the Cochairs of the Task Force, Dr. Donna Dean and Dr. Marianne Legato, who also 

shared in chairing each of the meetings. Dr. Dean, who was Director of the Division of Physiological Systems 

within the NIH Center for Scientific Review at the time that these meetings commenced and currently serves 

as Senior Advisor to the Deputy Director of NIH, is a member of the Coordinating Committee for Research 

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VOLUME 2

PREFACE
xiv

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

on Women’s Health (CCRWH), the advisory body composed of the Directors or designated representatives 

of NIH’s Institutes and Centers (ICs). In addition, she is Cochair of the CCRWH Research Subcommittee, 

which on behalf of the ICs assists ORWH in setting priorities for research and developing programs 

to implement such priorities. Dr. Marianne Legato, Professor of Clinical Medicine at Columbia University 

College of Physicians and Surgeons, is a charter member of the ACRWH, the body of 18 distinguished 

physicians, academicians, practitioners, scientists, and other individuals whose clinical practice, research 

specialization, or professional expertise includes a significant focus on research on women’s health, and 

who provide guidance and direction to ORWH and its policies and programs. She is a noted author 

on cardiovascular diseases of women and has recently established the Partnership for Women’s Health 

at Columbia University. 

In addition to those who served on the Task Force, the ACRWH, and the CCRWH, many others 

have assisted ORWH in these meetings and have played important roles in women’s health over the years. 

ORWH and all who are active in the movement to improve the health of women must also acknowledge 

the foresight of Dr. Edward N. Brandt, a charter member of the ACRWH, who established the first Public 

Health Service Task Force on Women’s Health in 1983, sparking a new level of federal commitment to 

addressing women’s health issues. This commitment was sustained by Dr. James Mason, Assistant Secretary 

for Health, by Dr. Audrey Manley, former Deputy Assistant Secretary for Health, and by Dr. William Raub, 

who, as Acting Director of NIH, established ORWH in September 1990. Dr. Ruth L. Kirschstein, who served 

as the first and continuous Cochair of the PHS Coordinating Committee on Women’s Health Issues from 

1983 until 1995, has a long history of activism on behalf of women in biomedical science and women’s 

health research; she served as the first Acting Director of ORWH and has continued to provide invaluable 

guidance and support to ORWH in her present position as Deputy Director of NIH.

ORWH and other efforts of the Federal Government to improve the health of women have greatly 

benefitted from the support and interest of many members of the United States Congress, as well as the 

Executive Branch. Important impetus and support for efforts to improve the health of women and NIH’s 

process of reviewing the research agenda on women’s health have been provided by the Secretary of the 

Department of Health and Human Services, Dr. Donna Shalala. This support was also evidenced by the 
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VOLUME 2

presence of Senator Barbara A. Mikulski, Congresswoman Connie A. Morella, Congresswoman Louise M. 

Slaughter, a representative of Congressman Louis Stokes, and the Director of the White House Office for 

Women’s Initiatives and Outreach, Audrey Tayse Haynes, at the final, national meeting, “Putting It All 

Together: The Agenda for Research on Women’s Health for the 21st Century,” held in November 1997. 

We gratefully acknowledge their support and contributions in helping NIH to chart a bold plan of 

action for improving the health of women in the next millennium.

Vivian W. Pinn, M.D.

Associate Director for Research on Women’s Health

Director, Office of Research on Women’s Health

National Institutes of Health

xvii

VOLUME 2

The Office of Research on Women’s Health wishes to acknowledge the many people who served 

on committees and working groups and who contributed their collective expertise to the creation 

of the Agenda for Research on Women’s Health for the 21st Century. ORWH wishes to thank:

• Ruth L. Kirschstein, M.D., Deputy Director, National Institutes of Health

• Task Force on the NIH Women’s Health Research Agenda for the 21st Century

• Advisory Committee on Research on Women’s Health

• Coordinating Committee on Research on Women’s Health

• Working Group Cochairs of the meetings of Beyond Hunt Valley: 

Research on Women’s Health for the 21st Century

Philadelphia, Pennsylvania

New Orleans, Louisiana

Santa Fe, New Mexico

Bethesda, Maryland

• More than 1,500 men and women who participated in the Public Hearings 

and Scientific Workshops. 

ACKNOWLEDGMENTS

xix

VOLUME 2

COCHAIRS

Donna Dean, Ph.D.

Senior Advisor to the Deputy Director, NIH 

(formerly, Director, Division of Physiological 

Systems, Center for Scientific Review, NIH)

Bethesda, Maryland

Marianne Legato, M.D.

Professor of Clinical Medicine 

Columbia University College of Physicians 

and Surgeons

New York, New York

TASK FORCE MEMBERS

Karen Antman, M.D.

Professor of Medicine and Pharmacology

Columbia University

Chief, Division of Medical Oncology

Columbia Presbyterian Comprehensive Cancer Center

New York, New York

Mary J. Berg, Pharm.D.

Professor

Division of Clinical and Administrative Pharmacy

University of Iowa

Iowa City, Iowa

Stephanie Bird, Ph.D.

Special Assistant to the Provost

Massachusetts Institute of Technology

Cambridge, Massachusetts

Edward Brandt, M.D., Ph.D.

Regents Professor and Director

University of Oklahoma, Center for Health Policy

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma

George Bryan, M.D.

Dean Emeritus, School of Medicine

University of Texas Medical Branch

Galveston, Texas

Leah Dickstein, M.D.

Professor and Associate Chair

Department of Psychiatry 

University of Louisville School of Medicine

Louisville, Kentucky

Mary Dufour, M.D., M.P.H.

Deputy Director

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

Bethesda, Maryland

Carola Eisenberg, M.D.

Lecturer in Psychiatry 

Dean, Student Affairs (Retired)

Harvard Medical School

Boston, Massachusetts

John Estrada, M.D.

Assistant Professor of Pediatrics

Meharry Medical College

Nashville, Tennessee

Bonita Falkner, M.D.

Professor of Medicine and Pediatrics

Institute for Women’s Health

Allegheny University of Health Sciences

Philadelphia, Pennsylvania

Sheryle Gallant, Ph.D.

Associate Professor of Psychology

Department of Psychology

University of Kansas

Lawrence, Kansas

John Greene, D.M.D., M.P.H.

Professor and Dean Emeritus

School of Dentistry

University of California at San Francisco

San Francisco, California

Jeane Ann Grisso, M.D., M.Sc.

Associate Professor of Medicine

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania

Hazel Harper, D.D.S.

President, National Dental Association

Hazel Harper and Associates

Washington, District of Columbia

TASK FORCE ON THE NIH WOMEN’S HEALTH RESEARCH

AGENDA FOR THE 21ST CENTURY

OFFICE OF RESEARCH ON WOMEN’S HEALTH, NATIONAL INSTITUTES OF HEALTH
xx

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Joseph Hurd Jr., M.D.

Chairman, Department of Gynecology

Lahey Hitchcock Clinic Medical Center

Burlington, Massachusetts

M. Margaret Kemeny, M.D., F.A.C.S.

Chief of Surgical Oncology

North Shore University Hospital

Manhasset, New York

Judith LaRosa, Ph.D., R.N., F.A.A.N.

Professor and Chair

Department of Community Health Sciences

Tulane University Medical Center

School of Public Health and Tropical Medicine

New Orleans, Louisiana

Angela Barron McBride, Ph.D., R.N., F.A.A.N.

Distinguished Professor and Dean

Indiana University School of Nursing

Indianapolis, Indiana

Sherry Mills, M.D., M.P.H.

Acting Chief, Cancer Control Research Branch 

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Donnica Moore, M.D.

Associate Director

Sandoz Pharmaceuticals Medical Education Center

Sapphire Women’s Health Group

Neshamic Station, New Jersey

Judy Norsigian

Co-Director

Boston Women’s Health Book Collective

Boston, Massachusetts

Jane Pearson, Ph.D.

Chief, Preventive Interventions Program

National Institute of Mental Health

National Institutes of Health

Bethesda, Maryland

David Robinson, Ph.D.

Program Director

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Helen Rodriguez-Trias, M.D.

Co-Director, Pacific Institute for Women’s Health

Western Consortium for Public Health

Los Angeles, California

Rosalie Sagraves, Pharm.D.

Dean, College of Pharmacy

University of Illinois at Chicago

Chicago, Illinois

Gloria Sarto, M.D., Ph.D.

Professor 

University of New Mexico School of Medicine

Albuquerque, New Mexico

Anne Sassaman, Ph.D.

Director, Division of Extramural Research and Training

National Institute of Environmental Health Sciences

National Institutes of Health

Research Triangle Park, North Carolina

Ora Lee Strickland, Ph.D.

Independence Professor

Nell Hodgson Woodruff School of Nursing

Emory University

Atlanta, Georgia

Ramona Tascoe, M.D., M.H.S.A.

Chair, Council on the Concerns of Women Physicians

Kaiser/National Medical Association

Oakland, California

Constance Weinstein, Ph.D.

National Heart, Lung, and Blood Institute (Retired)

National Institutes of Health

Bethesda, Maryland

Darlene Yee, Ed, C.H.E.S.

Professor and Director, Gerontology

College of Health and Human Services

San Francisco State University

San Francisco, California

Members-At-Large

Coordinating Committee on Research on Women’s 

Health Members

Advisory Committee on Research on Women’s

Health Members
xxi

VOLUME 2

Roster, 1996-1998

CHAIRPERSON

Vivian W. Pinn, M.D.

Associate Director for Research on Women’s Health

Director, Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

EXECUTIVE SECRETARY

Anne R. Bavier, M.N., F.A.A.N. (1996-1997)

Deputy Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

EXECUTIVE SECRETARY

Joyce Rudick (1997-1998)

Acting Deputy Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

COMMITTEE MEMBERS

Dyanne D. Affonso, Ph.D., F.A.A.N.

Atlanta, Georgia

Kathy S. Albain, M.D.

Associate Professor of Medicine

Division of Hematology and Oncology

Loyola University Medical Center

Maywood, Illinois 

Katherine L. Alley, M.D.

Director of Breast Services

Suburban Hospital Healthcare System

Bethesda, Maryland

Karen H. Antman, M.D.

Professor of Medicine and Pharmacology

Columbia University

Chief, Division of Medical Oncology

Columbia Presbyterian Comprehensive 

Cancer Center

New York, New York

Carol A. Aschenbrener, M.D.

Senior Vice President

Kaludis Consulting Group

Washington, District of Columbia

Byllye Y. Avery, M.Ed.

Founder

National Black Women’s Health Project

Provincetown, Massachusetts

Mary J. Berg, Pharm.D.

Professor

Division of Clinical and Administrative Pharmacy

College of Pharmacy

University of Iowa

Iowa City, Iowa 

Edward N. Brandt, Jr., M.D., Ph.D.

Professor and Director

Center for Health Policy Research

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma

David M. Brown, M.D.

Professor of Pediatrics, Laboratory Medicine, 

and Pathology 

Head, Division of Pediatric Endocrinology

School of Medicine

Division of Pediatric Endocrinology

University of Minnesota

Minneapolis, Minnesota 

George T. Bryan, M.D.

Dean Emeritus, School of Medicine

The University of Texas Medical Branch

Galveston, Texas

Linda Burhansstipanov, M.S.P.H., Dr.P.H.

Director, Native American Cancer Initiatives

Pine, Colorado 

Carola Eisenberg, M.D.

Lecturer in Psychiatry

Dean of Students (Retired)

Harvard Medical School

Cambridge, Massachusetts

ADVISORY COMMITTEE ON RESEARCH ON WOMEN’S HEALTH

NATIONAL INSTITUTES OF HEALTH 
xxii

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

John J. Estrada, M.D.

Assistant Professor of Pediatrics

Department of Pediatrics

Meharry Medical College

Nashville, Tennessee 

Sheryle J. Gallant, Ph.D.

Associate Professor of Psychology

Department of Psychology

University of Kansas

Lawrence, Kansas 

W. Lou Glasse, M.S.W.

President Emerita

Older Women’s League

Vassar College

Poughkeepsie, New York

Irma E. Goertzen

President and Chief Executive Officer

Magee-Women’s Hospital

Pittsburgh, Pennsylvania 

John C. Greene, D.M.D., M.P.H.

Professor and Dean Emeritus

School of Dentistry

University of California at San Francisco

San Rafael, California

Joseph K. Hurd, M.D.

Chairman

Department of Gynecology

Lahey Clinic Medical Center

Burlington, Massachusetts 

Barbara A. Koenig, Ph.D.

Senior Research Scholar

Executive Director

Stanford University Center for Biomedical Ethics

Palo Alto, California

LaSalle D. Leffall, Jr., M.D.

Charles R. Drew Professor and Chairman

Department of Surgery

Howard University Hospital

Washington, District of Columbia

Marianne J. Legato, M.D., F.A.C.P.

Professor of Clinical Medicine

Columbia University College of Physicians 

and Surgeons

New York, New York 

Angela Barron McBride, Ph.D., R.N., F.A.A.N.

Distinguished Professor and Dean

Indiana University School of Nursing

Indianapolis, Indiana

Linda C. Niessen, D.M.D., M.P.H.

Professor and Chair

Department of Public Health Sciences 

Baylor College of Dentistry

Dallas, Texas

Suzanne Oparil, M.D.

Director

Vascular Biology and Hypertension Program

Division of Cardiovascular Disease

University of Alabama at Birmingham

Birmingham, Alabama

Amelie G. Ramirez, Dr.P.H.

Associate Professor

Associate Director, Center for Cancer 

Control Research

Baylor College of Medicine

Houston, Texas

Gloria E. Sarto, M.D., Ph.D.

Professor and Chair

Department of Obstetrics and Gynecology

School of Medicine

University of New Mexico

Albuquerque, New Mexico

Marjorie M. Shultz, J.D., M.A.T.

Professor of Law

Boalt Hall School of Law

University of California at Berkeley

Berkeley, California 

Nancy Sabin Wexler, Ph.D.

Higgins Professor of Neuropsychology

Columbia University College of Physicians 

and Surgeons

New York, New York 

Nancy A. Fugate Woods, Ph.D., R.N., F.A.A.N.

Dean, School of Nursing

University of Washington

Director, Center for Women’s Health Research

Seattle, Washington
xxiii

VOLUME 2

COORDINATING COMMITTEE ON RESEARCH ON

WOMEN’S HEALTH

NATIONAL INSTITUTES OF HEALTH

Roster, 1996-1998

Norman Anderson, Ph.D.

Director

Office of Behavioral and Social Sciences Research 

Tina Blakeslee

Legislative Liaison and Analysis Branch

Office of the Director

Kristina Borror

Scientist

Office of Science Policy

Joy Boyer

Program Analyst

National Center for Human Genome Research

Stephanie Bursenos

Assistant Director for Program Coordination

John E. Fogarty International Center 

Virginia Cain, Ph.D.

Special Assistant to the Director

Office of Behavioral and Social Sciences Research 

Jill Carrington, Ph.D.

Program Administrator

National Center for Research Resources 

Joan Chamberlin

Information Officer

Division of Computer Research and Technology

Paul Coates, Ph.D. 

Deputy Director

Division of Nutrition Research Coordination

National Institute of Diabetes and Digestive 

and Kidney Diseases

Lois Ann Colaianni, Ph.D.

Associate Director, Library Operations

National Library of Medicine

Alison E. Cole, Ph.D. 

Program Administrator

PBC Program

National Institute of General Medical Sciences 

Donna Dean, Ph.D.

Director

Division of Physiological Systems

Center for Scientific Review

Amy Donahue, Ph.D.

Acting Chief

Hearing and Balance/Vestibular Sciences Branch

National Institute on Deafness and Other 

Communication Disorders

Deborah Dozier-Hall

Assistant to Chief for Education

Warren Grant Magnuson Clinical Center

Mary Dufour, M.D., M.P.H.

Deputy Director

National Institute on Alcohol Abuse and Alcoholism 

Robert Eisinger, Ph.D.

Senior Program Analyst

Office of AIDS Research

Shirley Everest

Acting Federal Women’s Program Manager

Office of Equal Opportunity 

Loretta Finnegan, M.D.

Director

Women’s Health Initiative

Lorainne Fitzsimmons

Program Analyst

National Institute of Neurological Disorders and Stroke
xxiv

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Julia Freeman, Ph.D.

Director

Centers Program

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases

Barbara Fuller, J.D.

Senior Policy Analyst

National Human Genome Research Institute 

Harriet Gordon

Medical Officer, General Clinical Research 

Centers Program

National Center for Research Resources

Robin Hamilton

Program Analyst

National Institute of Neurological Disorders and Stroke 

Eleanor Hanna, Ph.D.

Special Expert

Division of Biometry and Epidemiology

National Institute on Alcohol Abuse and Alcoholism 

J. Taylor Harden, Ph.D. 

Assistant to the Director for Special Populations

National Institute on Aging

Barbara Harrison 

Special Projects Officer

Scientific Program and Policy Analysis

National Institute of Diabetes and Digestive 

and Kidney Diseases

Janyce Hedetniemi

Director

Office of Community Liaison

Office of the Director 

Caroline Holloway

Health Scientist Administrator

Biomedical Technology

National Center for Research Resources 

Sharon Hrynkow, Ph.D.

Science Policy Administrator

Office of International Science Policy and Analysis

John E. Fogarty International Center

Carole Hudgings, Ph.D., F.A.A.N.

Senior Program Administrator

National Institute of Nursing Research

Chyren Hunter, Ph.D.

Health Scientist Administrator

Division of Human Communication 

National Institute on Deafness and Other

Communication Disorders

Laura James

Nurse Scientist Administrator

National Institute of Nursing Research

Walter Jones

Deputy Director of Management and Operations

Warren Grant Magnuson Clinical Center

Bonnie Kalberer

Special Assistant/OSP

Office of the Director

Barbara Kellner

Technical Information Specialist

National Institute on Aging

Sooja Kim, Ph.D.

Chief, Nutritional and Metabolic Sciences IRG

Center for Scientific Review

Dushanka Kleinman, D.D.S.

Deputy Director

National Institute of Dental Research

Natalie Kurinij

Health Scientist Administrator

National Eye Institute

Anna Levy

Program Analyst

National Cancer Institute

Ellen S. Liberman, Ph.D.

Director

Lens, Cataract, and Glaucoma Programs 

National Eye Institute
xxv

VOLUME 2

Barbara Liu

Director

Office of Science and Technology

National Heart, Lung, and Blood Institute 

Angela Magliozzi

Women’s Health Program Coordinator

National Institute of Allergy and Infectious Diseases 

Pamela Marino, Ph.D.

Co-Director, PRATT Program

National Institute of General Medical Sciences

Bernadette Marriott, Ph.D.

Director, Office of Dietary Supplements

Office of the Director

Dorothy McKelvin

Contract Specialist/OEO

Office of the Director

Sheila Newton

Director

Office of Program Planning and Evaluation

National Institute of Environmental Health Sciences 

Cherie Nichols

Chief, Planning and Evaluation Branch

National Cancer Institute

Delores Parron, Ph.D.

Associate Director for Special Populations

National Institute of Mental Health

Estella Parrott, M.D. 

Coordinator of Research Programs

National Institute of Allergy and Infectious Diseases 

Nancy Pearson, Ph.D.

Chief, Genetics Section IRB

Center for Scientific Review

Sherman Ragland, Ph.D.

Deputy Associate Director for Special Populations

National Institute of Mental Health

Linda Reck

International Policy Analyst

John E. Fogarty International Center

Mary Ann Robinson

Senior Scientist

National Institute of Allergy and Infectious Diseases 

Adele Roman, M.S.N.

Deputy Women’s Health Coordinator

National Institute on Drug Abuse 

Angela Ruffin, Ph.D.

Outreach Librarian

National Library of Medicine

John Ruffin, Ph.D.

Director, Office of Research on Minority Health

Office of the Director

Anne Sassaman, Ph.D.

Director, Division of Extramural Research and Training

National Institute of Environmental Health Sciences 

Belinda Seto, Ph.D.

Office of Extramural Research

Office of the Director

Louis Sibal, Ph.D.

Director, Office of Laboratory Research

Office of the Director 

Sandra Smith-Gil

Senior Scientist 

National Cancer Institute

Dorothy Sogn, M.D.

Clinical Research 

National Center for Research Resources

Susan Stark

Writer-Editor

Planning Office

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases

Mary Stephens-Frazier

Health Scientist Administrator

National Institute of Nursing Research

Patricia Straat, Ph.D.

Deputy Chief for Referral

Center for Scientific Review
xxvi

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Anne Thomas

Director

Office of Communications

Office of the Director 

Elizabeth Thomson

Assistant Director

Clinical Genetics Branch

National Human Genome Research Institute 

Patricia Turner

Program Analyst 

National Institute of Neurological Disorders and Stroke 

Donna Vogel, M.D., Ph.D.

Medical Officer, Reproductive Sciences

National Institute of Child Health and Human 

Development 

Carol E. Vreim, Ph.D.

Deputy Director, Division of Lung Diseases

National Heart, Lung, and Blood Institute

Anita Weinblatt, Ph.D.

Chief, Immunology Initial Review Group 

Center for Scientific Review

CoraLee Wetherington, Ph.D.

Women’s Health Coordinator 

National Institute on Drug Abuse

Judith Whalen

Associate Director for Science Policy, Analysis, 

and Communication

National Institute of Child Health and Human 

Development 

Susan Wise

Program Analyst

Planning and Legislation Section

National Institute of Dental Research

Chris Zimmerman

Program Analyst 

National Institute of General Medical Sciences
BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH FOR THE 21ST CENTURY

xxvii

VOLUME 2

PHILADELPHIA, PENNSYLVANIA

SEPTEMBER 25-27, 1996

WORKING GROUP COCHAIRS

CANCER

Karen Antman, M.D.

Professor of Medicine 

Chief, Division Medical Oncology

Columbia University

New York, New York

Edward Trimble, M.D., M.P.H.

Head, Surgery Section

Cancer Therapy Evaluation Program

Division of Cancer Treatment, Diagnosis and Centers

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

CARDIOVASCULAR DISEASE AND VASCULAR BIOLOGY

Suzanne Oparil, M.D.

Director

Vascular Biology and Hypertension Program

University of Alabama at Birmingham

Birmingham, Alabama

David Robinson, Ph.D.

Program Director 

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

HEALTH IMPACT AND HEALTH OUTCOMES: 

ADVANCES IN BIOTECHNOLOGY

Maria Freire, Ph.D.

Director, Office of Technology Transfer

National Institutes of Health

Bethesda, Maryland

Judy Norsigian

Co-Director

Boston Women’s Health Book Collective

Boston, Massachusetts

IMMUNOLOGY

Betty Diamond, M.D.

Professor 

Departments of Microbiology and Immunology

and Medicine 

Albert Einstein College of Medicine

Bronx, New York

Donna M. Murasko, Ph.D.

Professor and Chair

Department of Microbiology and Immunology

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania

Susana Serrate-Sztein, M.D.

Director, Arthritis Program 

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases

National Institutes of Health

Bethesda, Maryland

INFECTIOUS DISEASES AND EMERGING INFECTIONS

Howard Minkoff, M.D.

Professor of Obstetrics and Gynecology

Director of Maternal-Fetal Medicine

SUNY Health Science Center at Brooklyn

Brooklyn, New York

Sharilyn K. Stanley, M.D.

Special Assistant for Science Policy

Office of the Director

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

MENTAL AND ADDICTIVE DISORDERS

Delores L. Parron, Ph.D.

Associate Director for Special Populations

National Institute of Mental Health

National Institutes of Health

Bethesda, Maryland
xxviii

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Elizabeth Young, M.D.

Associate Professor Psychiatry

Mental Health Research Institute

University of Michigan

Ann Arbor, Michigan 

NEUROSCIENCE, BEHAVIOR, AND THE HEALTH OF

WOMEN ACROSS THE LIFE SPAN

Constance W. Atwell, Ph.D.

Associate Director, Extramural Activities

National Institute of Neurological Disorders and Stroke 

National Institutes of Health

Bethesda, Maryland

Raquel E. Gur, M.D., Ph.D.

Professor and Director of Neuropsychiatry

University of Pennsylvania

Philadelphia, Pennsylvania

PREVENTIVE INTERVENTIONS: 

ADDRESSING GENDER DIFFERENCES

Marilyn Gaston, M.D.

Assistant Surgeon General

Director, Bureau of Primary Health Care 

Health Resources and Services Administration

Rockville, Maryland

Phyllis Greenberger, M.S.W.

Executive Director

Society for the Advancement of Women’s 

Health Research

Washington, District of Columbia

Jane Pearson, Ph.D.

Chief, Clinical and Developmental PsychoPathology Program

Mental Disorders of the Aging Research Branch

National Institute of Mental Health

National Institutes of Health

Bethesda, Maryland

RACIAL, ETHNIC, AND CULTURAL DIVERSITY IN

CLINICAL RESEARCH

Virginia Cain, Ph.D.

Special Assistant to the Director

Office of Behavioral and Social Sciences Research

Office of the Director

National Institutes of Health

Bethesda, Maryland

Helen Rodriguez-Trias, M.D.

Co-Director

Pacific Institute for Women’s Health

Western Consortium for Public Health

Los Angeles, California

REPRODUCTIVE HEALTH

Michelle Berlin, M.D., M.P.H.

Assistant Professor of Obstetrics and Gynecology 

and Epidemiology 

Center for Clinical Epidemiology and Biostatistics

University of Pennsylvania

Philadelphia, Pennsylvania

Donna Vogel, M.D., Ph.D.

Associate Chief for Clinical Research Reproductive 

Sciences Branch 

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Eugene Washington, M.D., M.P.H., M.Sc. 

Professor and Chair

Department of Obstetrics and Gynecology 

University of California at San Francisco

San Francisco, California

RESEARCH DESIGNS: GENDER

Otis Brawley, M.D.

Director, Office of Special Populations

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

George W. Counts, M.D.

Director

Office of Research on Minority and Women’s Health

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

Rosalie Sagraves, Pharm.D.

Dean and Professor

College of Pharmacy

University of Illinois at Chicago

Chicago, Illinois
xxix

VOLUME 2

RESEARCH DESIGN: MULTIDISCIPLINARY PERSPECTIVES

Patricia Grady, Ph.D., R.N.

Director

National Institute of Nursing Research

National Institutes of Health

Bethesda, Maryland

Brian Strom, M.D., M.P.H.

Professor and Chair

Department of Biostatistics and Epidemiology

Director, Center for Clinical Epidemiology 

and Biostatistics

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania

WOMEN IN BIOMEDICAL CAREERS: 

ISSUES OF IMPORTANCE FOR YOUNG INVESTIGATORS

Anne Sassaman, Ph.D.

Director, Division of Extramural Research and Training

National Institute of Environmental Health Sciences

National Institutes of Health

Research Triangle Park, North Carolina

Eleanor Shore, M.D., M.P.H.

Dean, Faculty Affairs 

Harvard Medical School

Boston, Massachusetts

xxxi

VOLUME 2

BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH FOR THE 21ST CENTURY

NEW ORLEANS, LOUISIANA

JUNE 12-13, 1997

WORKING GROUP COCHAIRS

PRENATAL, INFANCY, AND CHILDHOOD YEARS

Daisy Granado-Villar, M.D.

Director of Preventive Medicine Health

Promotion Division

Miami Children’s Hospital

Miami, Florida

David Robinson, Ph.D.

Director, Vascular Research Program

National, Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Joan Spyker-Crammer, Ph.D.

Professor of Pediatrics and Toxicology

University of Arkansas for Medical Sciences

Department of Pediatrics at Arkansas

Children’s Hospital

Little Rock, Arizona

ADOLESCENT YEARS

Susan Abdalian, M.D.

Associate Professor of Clinical Pediatrics

Department of Adolescent Medicine

Tulane University Medical School

New Orleans, Louisiana 

Thomas Lasater, Ph.D.

Director, Division of Research

Center for Primary Care and Prevention

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island

Anne Willoughby, M.D., M.P.H.

Chief, Pediatric, Adolescent and Maternal AIDS Branch

Center for Research for Mothers and Children

National Institute of Child Health and Human

Development

National Institutes of Health

Bethesda, Maryland

REPRODUCTIVE AND MIDDLE YEARS

Linda Alexander, Ph.D.

Vice President for Women’s Health

United Information Systems, Inc.

Bethesda, Maryland

Gwen W. Collman, Ph.D.

Scientific Programs Administrator

Division of Extramural Research and Training

National Institute of Environmental Health Sciences

National Institutes of Health

Research Triangle Park, North Carolina

Gloria Richard-Davis, M.D.

Assistant Professor Obstetrics-Gynecology

Tulane University Medical Center

New Orleans, Louisiana 

PERIMENOPAUSAL AND POSTMENOPAUSAL YEARS

Anuradha V. Rao, M.D.

Director, Women’s Heart Program

Clinical Instructor of Medicine

Department of Medicine

Tulane University Medical Center

New Orleans, Louisiana 

Sherry Sherman, Ph.D.

Director, Endocrine and Osteoporosis Research

National Institute on Aging

National Institutes of Health

Bethesda, Maryland

Sarah Moody Thomas, Ph.D.

Associate Director

Stanley Scott Cancer Center

Louisiana State University Medical Center

New Orleans, Louisiana
xxxii

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

ELDERLY AND FRAIL ELDERLY YEARS

Mary C. Dufour, M.D., M.P.H.

Deputy Director

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

Bethesda, Maryland

Carola Eisenberg, M.D.

Lecturer in Psychiatry

Dean for Student Affairs (Retired)

Harvard Medical School

Boston, Massachusetts

W. Lou Glasse, M.S.W.

President Emerita

Older Women’s League

Vassar College

Poughkeepsie, New York

Veronica J. Scott, M.D., M.P.H.

Associate Professor

Director, Center on Aging

Meharry Medical College

Nashville, Tennessee
xxxiii

VOLUME 2

BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH FOR THE 21ST CENTURY

SANTA FE, NEW MEXICO

JULY 21-23, 1997

WORKING GROUP COCHAIRS

PRENATAL YEARS

David Robinson, Ph.D.

Director, Vascular Research Program

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Susan Scott, M.D.

Department of Pediatrics

University of New Mexico

Albuquerque, New Mexico

INFANCY AND CHILDHOOD YEARS

Marilyn Duncan, M.D.

Pediatric Oncology Program

University of New Mexico

Albuquerque, New Mexico

Gilman Grave, M.D.

Chief, Endocrinology, Nutrition, and Growth Branch

National Institute of Child Health and Human

Development

National Institutes of Health

Bethesda, Maryland

ADOLESCENT YEARS

Sally Davis, Ph.D.

Director, Center for Health Promotion and

Disease Prevention

Associate Professor, Department of Pediatrics

University of New Mexico

Albuquerque, New Mexico

Susan Newcomer, Ph.D.

Statistician (Demography)

Demographic and Behavioral Sciences Branch

National Institute of Child Health and Human

Development

National Institutes of Health

Bethesda, Maryland

REPRODUCTIVE AND MIDDLE YEARS

Danuta Krostoki, Ph.D.

Director, Biological Sciences and Career 

Development Program

National Institute of Child Health and Human

Development

National Institutes of Health

Bethesda, Maryland

Jael Silliman, Ed.D.

Professor, Women’s Studies

University of Iowa

Iowa City, Iowa

PERIMENOPAUSAL YEARS

Louis DePaolo, Ph.D.

Health Scientist Administrator

National Institute of Child Health and Human 

Development

National Institutes of Health

Bethesda, Maryland

Nancy Fugate Woods, Ph.D., R.N., F.A.A.N.

Associate Dean for Research

Professor, School of Medicine

University of Washington

Seattle, Washington

POSTMENOPAUSAL YEARS

David Coultas, M.D.

Epidemiology and Cancer Control

University of New Mexico

Albuquerque, New Mexico

Loretta Finnegan, M.D.

Director, Women’s Health Initiative

National Institutes of Health

Bethesda, Maryland
xxxiv

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

ELDERLY AND FRAIL ELDERLY YEARS

W. Lou Glasse, M.S.W.

President Emerita

Older Women’s League

Vassar College

Miriam Kelty, Ph.D.

Associate Director

National Institute on Aging

National Institutes of Health

Bethesda, Maryland

CAREER ISSUES FOR SPECIAL POPULATIONS OF

WOMEN SCIENTISTS

Jaleh Daie, Ph.D.

National Oceanic and Atmospheric Administration

Washington, District of Columbia

Estella Parrott, M.D., M.P.H.

Coordinator of Research Programs

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland
xxxv

VOLUME 2

BETHESDA, MARYLAND

NOVEMBER 17-19, 1997

WORKING GROUP COCHAIRS

ALCOHOL, TOBACCO, AND OTHER DRUG USE, 

DISORDERS, AND CONSEQUENCES

Mary C. Dufour, M.D., M.P.H.

Deputy Director

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

Bethesda, Maryland

Mary E. McCaul, Ph.D.

Johns Hopkins Hospital Comprehensive 

Women’s Center 

Baltimore, Maryland 

Cora Lee Wetherington, Ph.D.

Health Scientist Administrator

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland

Sharon Wilsnak, Ph.D.

Chester Fritz Distinguished Professor

Department of Neuroscience

University of North Dakota

School of Medicine

Grand Forks, North Dakota 

BEHAVIORAL AND SOCIAL SCIENCES

Virginia S. Cain, Ph.D.

Special Assistant to the Director

Office of Behavioral and Social Sciences Research

National Institutes of Health

Bethesda, Maryland

Karen Scott Collins, M.D.

Assistant Vice President

The Commonwealth Fund

New York, New York

BONE AND MUSCULOSKELETAL DISORDERS

Barbara Drinkwater, Ph.D.

Pacific Medical Center

Seattle, Washington

Joan A. McGowan, Ph.D.

Chief, Musculoskeletal Diseases Branch

National Institute of Arthritis and Musculoskeletal

and Skin Diseases

National Institutes of Health

Bethesda, Maryland

Laura Tosi, M.D.

Associate Professor of Orthopaedic Surgery 

and Pediatrics

George Washington University School of Medicine

Children’s National Medical Center

Washington, District of Columbia

CANCER

Karen Antman, M.D.

Director, Herbert Irving Comprehensive Cancer Center

Professor of Medicine, Columbia University

Chief, Division of Medical Oncology

Presbyterian Comprehensive Cancer Center

New York, New York

Edward L. Trimble, M.D., M.P.H.

Head, Surgery Section

Cancer Therapy Evaluation Program

Division of Cancer Treatment, Diagnosis and Centers

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH FOR THE 21ST CENTURY
xxxvi

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

CARDIOVASCULAR DISEASES

Judith H. LaRosa, Ph.D., R.N., F.A.A.N.

Professor and Chair 

Department of Community Health Sciences

Tulane University School of Public Health 

and Tropical Medicine

New Orleans, Louisiana

David Robinson, Ph.D.

Program Director

Vascular Research Program

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Nanette K. Wenger, M.D.

Professor of Medicine

Director, Cardiac Clinics

Division of Cardiology

Emory University

School of Medicine

Atlanta, Georgia 

CAREER ISSUES FOR WOMEN SCIENTISTS

Catherine Didion

Executive Director

Association for Women in Science

Washington, District of Columbia

Joan Y. Reede, M.D., M.P.H., M.S.

Assistant Dean, Faculty Development and Diversity

Minority Faculty Development Program

Boston, Massachusetts

Joan P. Schwartz, Ph.D.

Division of Intramural Research

National Institutes of Neurological Disorders

and Stroke

National Institutes of Health

Bethesda, Maryland

Eleanor G. Shore, M.D., M.P.H.

Dean for Faculty Affairs

Harvard Medical School

Boston, Massachusetts

DIGESTIVE DISEASES

James E. Everhart, M.D., M.P.H.

Chief, Epidemiology and Clinical Trials Branch

National Institute of Diabetes and Digestive 

and Kidney Diseases

National Institutes of Health

Bethesda, Maryland

Joanne Wilson, M.D.

Duke University Medical Center

Division of Gastroenterology

Durham, North Carolina 

Jacqueline Wolf, M.D.

Brigham and Women’s Hospital

Gastro Division

Boston, Massachusetts 

IMMUNITY AND AUTOIMMUNE DISEASES

Elaine Collier, M.D.

Chief, Autoimmunity Section

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

Betty Diamond, M.D.

Professor

Department of Microbiology and Immunology, 

and Medicine

Yeshiva University

Albert Einstein College of Medicine

Bronx, New York

Anita Corman Weinblatt, Ph.D.

Scientific Review Administrator

Division of Research Grants

National Institutes of Health

Bethesda, Maryland

Caroline Whitacre, Ph.D.

Ohio State University

Department of Microbiology/Immunology

Columbus, Ohio
xxxvii

VOLUME 2

MENTAL DISORDERS

Delores L. Parron, Ph.D.

Associate Director for Special Populations

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

M. Katherine Shear, M.D.

University of Pittsburgh

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania

NEUROSCIENCE

Constance Atwell, Ph.D.

Director, Extramural Activities

National Institute of Neurological Disorders and Stroke

National Institutes of Health

Bethesda, Maryland

Howard Kurtzman, Ph.D.

Cognitive Science Program

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Bruce S. McEwen, Ph.D.

Laboratory of Neuroendocrinology

Rockefeller University

New York, New York

ORAL HEALTH

Marjorie Jeffcoat, D.M.D.

Rosen Professor and Chair

Department of Periodontics

University of Alabama – Birmingham

School of Dentistry

Birmingham, Alabama

Maryann Redford, D.D.S., M.P.H.

Health Scientist Administrator

Division of Extramural Research

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Susan F. Silverton, M.D., Ph.D.

Enid Neidle Fellow (AADS)

University of Pennsylvania

School of Dental Medicine

Philadelphia, Pennsylvania

PHARMACOLOGIC ISSUES

Mary Berg, Pharm.D.

Professor

Division of Clinical and Administrative Pharmacy

College of Pharmacy

University of Iowa

Iowa City, Iowa

Jeanne N. Ketley, Ph.D.

Chief, Cardiovascular Sciences Initial Review Group

Scientific Review Administrator

Pharmacology Study Group

Center for Scientific Review

National Institutes of Health

Bethesda, Maryland

Ruth Merkatz, Ph.D., R.N., F.A.A.N.

Director, Office of Women’s Health

Pfizer, Inc.

New York, New York

REPRODUCTIVE ISSUES

Florence P. Haseltine, M.D., Ph.D.

Director for the Center for Population Research

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Gloria Sarto, M.D., Ph.D.

Professor 

University of New Mexico School of Medicine 

Albuquerque, New Mexico 

Wulf A. Utian, M.D., Ph.D.

Director, Department of Ob/Gyn

Department of Reproductive Biology

McDonald Hospital for Women

Case Western Reserve University

Cleveland, Ohio
xxxviii

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Donna L. Vogel, M.D., Ph.D.

Center for Population Research

National Institute of Child Health and 

Human Development 

National Institutes of Health

Bethesda, Maryland

UROLOGIC AND KIDNEY CONDITIONS

Deborah Erickson, M.D.

Division of Urology

Hershey Medical School

Hershey, Pennsylvania 

Leroy M. Nyberg, M.D., Ph.D.

Director, Urology Program

National Institute of Diabetes and Digestive

and Kidney Diseases

National Institutes of Health

Bethesda, Maryland

Ebrahim Versi, M.D., Ph.D.

Department of Urology

Brigham and Women’s Hospital

Boston, Massachusetts
REVISITING THE NIH RESEARCH

AGENDA ON WOMEN’S HEALTH

FOR THE 21 S T CENTURY: 

A COLLABORATION BETWEEN 

NIH AND THE BROADER 

WOMEN’S HEALTH COMMUNITY

As the National Institutes of Health (NIH) 

Office of Research on Women’s Health 

(ORWH) engages the scientific, health care,

public policy, advocacy, and other communities in 

a review and revision of the NIH research agenda on

women’s health for the 21st century, it is salutary to

examine the history of efforts to improve the health 

of women through research, and the steps that led 

NIH to the landmark series of four scientific workshops held in 1996 and 1997.

There is no question that research is central 

to providing the scientific foundation for changes 

and improvements in health practices and policies.

Expanding our understanding of normal and abnormal

biologic processes and behavior can result in improved

prevention, diagnosis, and treatment of diseases, disabilities, and other conditions that affect the health 

of women and their families. Yet, despite the importance to the United States of improving the health 

status of women across the life span, the emergence 

of women’s health issues among our nation’s priorities did not occur overnight. We owe much of the

increased focus of the scientific community on 

women’s health to many individuals, groups, and 

organizations that have been working to improve 

the health of women for some time. These include 

the Boston Women’s Health Book Collective, the

National Women’s Health Network, the National 

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VOLUME 2

INTRODUCTION

Black Women’s Health Network, the Society for 

the Advancement of Women’s Health Research, and

many others, some of whom provided testimony 

during our public hearings. For many years, these

organizations have been working “in the trenches,”

calling attention to the need to focus our attention 

on women’s health. Nevertheless, only in recent 

years has the Federal Government recognized women’s

health as a real issue requiring a real remedy. Today,

thanks to the efforts of advocates and scientists in 

and outside the Federal Government, we are beginning to make progress.

PHS Task Force and the Establishment of ORWH

In 1983, the Assistant Secretary for Health, Dr.

Edward N. Brandt, Jr., established the Public Health

Service (PHS) Task Force on Women’s Health Issues 

to examine the role of the Department of Health and

Human Services in addressing women’s health. In a

report published in 1985, this Task Force made a 

number of recommendations on a broad array of

women’s health issues relevant to the entire life span 

of girls and women. At that time, Dr. Brandt stated, 

“I am committed to seeing that this report results in

action that is beneficial to the women of America.”

Among the most pertinent recommendations of the

Task Force report was one which said that “Biomedical and behavioral research should be expanded to

ensure emphasis on conditions and diseases unique 

to, or more prevalent in, women in all age groups.”1

Following publication of the report of the PHS

Task Force on Women’s Health in 1985, NIH established a policy for the inclusion of women in clinical

research. Two years later, in 1987, the policy was

incorporated into and published in the NIH Guide 

to Grants and Contracts.

2 In a later 1987 version 

Vivian W. Pinn, M.D.

Associate Director for Research on Women’s Health

Director, Office of Research on Women’s Health

National Institutes of Health
At the same time, Dr. Raub stated that “The new

Office will have the authority and responsibility to act

with and on behalf of the NIH Director to monitor 

and coordinate the activities of the constituent IC’s 

at NIH in regard to research on women’s health . . .”

With these words, ORWH was established and

given the broad mission that still directs the activities

of the Office today. This mission encompasses:

• Establishing NIH-wide goals and policies for

research related to women’s health.

• Developing a plan to increase NIH-supported

research on women’s health, then implementing

and monitoring its effects.

• Coordinating NIH activities undertaken in 

performing women’s health research.

• Providing advice and staff support to the 

NIH Director and senior NIH staff regarding the overall direction of and approaches 

to NIH programs of research related to 

women’s health.

• Interacting with the scientific and medical 

communities, organizations with an interest 

in women’s health, and other components 

of government to inform them of NIH programs related to women’s health.

• Developing special initiatives to increase the 

participation of women as subjects in clinical

research and of institutions and investigators 

in performing research on women’s health.

One of the earliest announcements of activity 

by this new office was made on that same September

day by Dr. Ruth L. Kirschstein, who promised that 

“. . . As one of its most important activities, the 

Office, this fall, will convene a planning group to 

prepare the background for a major conference 

which will serve to set an agenda for NIH research 

on women’s health . . . “

2

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

of the NIH Guide, a policy encouraging the inclusion

of minorities in clinical studies was first published.3

In 1990, the Congressional Caucus for Women’s

Issues requested that the United States General

Accounting Office (GAO) study NIH’s implementation of the guidelines for inclusion of women. The

resulting GAO report stated that the implementation 

of the policy for the inclusion of women was lacking,

the implementation was slow and not well communicated, gender analysis was not implemented, and the

impact of policy could not be determined.4

In September 1990, just 3 months after the release

of the GAO findings, the subsequent media coverage

and public reaction catalyzed NIH to establish the

Office of Research on Women’s Health. The Office 

was set up by Dr. William Raub to serve as the focal

point for women’s health research at NIH, working 

in a collaborative partnership with NIH Institutes 

and Centers (ICs). ORWH was announced at an 

NIH roundtable meeting with representatives of 

the Congressional Caucus for Women’s Issues on 

September 10, 1990. A press release from the U.S.

Department of Health and Human Services at the 

time of this meeting stated that:

. . .The ORWH is charged with assuring that

research conducted and supported by NIH appropriately addresses issues regarding women’s health and 

that there is appropriate participation of women in

clinical trials . . . 

. . .The Office will establish NIH-wide goals 

and policies for research related to women’s health. 

It will also coordinate NIH activities undertaken in 

performing such research. Finally, the Office will 

interact with the scientific and medical communities,

organizations with an interest in women’s health and

other components of government to inform them of

NIH’s programs related to women’s health, identify

areas of research that need emphasis and involve 

them in efforts to expand and encourage research 

on women’s health.
3

VOLUME 2

As a result, one year later, in September 1991, 

ORWH held public hearings and a scientific workshop

at Hunt Valley, Maryland, to set the NIH agenda for

research on women’s health issues. The report from

that meeting, Report of the National Institutes of Health:

Opportunities for Research on Women’s Health,

6 commonly referred to as the Hunt Valley Report, served 

as the basis for NIH’s research priorities in women’s

health for 7 years.

At the Hunt Valley meeting, discussions centered

around life span concepts for women’s health and

cross-cutting areas of science. These included:

Life Span

Birth to Young Adulthood

Young Adulthood to Perimenopausal Years

Perimenopausal to Mature Years

Mature Years

Cross-cutting Science

Reproductive Biology 

Early Developmental Biology 

Aging Processes 

Cardiovascular Function and Disease 

Malignancy 

Immune Function and Infectious Diseases 

In addition, speakers addressed morbidity 

and mortality in women, ethical and legal issues,

women as research subjects, and women in biomedical careers.

Thus were launched the programs of ORWH 

to “expand and encourage” research on women’s 

health. In 1993, ORWH was legislatively mandated 

in NIH Revitalization Act.6 Women’s health research 

at NIH is a partnership between ORWH and the NIH

institutes and centers. Over the past 7 years, ORWH’s

responsibilities and major program efforts have

increased, and while there is still a lot to be done, 

we have made some progress. 

NIH Mandate for the Inclusion of Women and 

Minorities in Clinical Research

The establishment and implementation of 

policies for the inclusion of women and minorities 

in clinical research funded by NIH has its origins 

in the response to the PHS Task Force on Women’s

Health Issues and in response to the GAO report 

of 1990. ORWH has assumed leadership in implementing policies requiring the inclusion of women 

and minorities in human subject research. Wanting 

to assure that the policies for inclusion were firmly

implemented by NIH, Congress made what had 

previously been policy into Public Law, through 

a section in the NIH Revitalization Act of 1993 

(Public Law 103-43), entitled “Women and 

Minorities as Subjects in Clinical Research.”

The NIH Revitalization Act of 1993 essentially 

put forth the existing NIH policies but with four 

major differences:

• NIH must ensure that women and minorities 

and their subpopulations be included in all 

human subject research;

• Women and minorities and their subpopulations

must be included in phase III clinical trials in

numbers adequate to allow for valid analyses 

of differences in intervention effect;

• Cost is not allowed as an acceptable reason 

for excluding these groups; and,

• NIH must initiate programs and support for 

outreach efforts to recruit and retain women 

and minorities and their subpopulations as 

volunteers in clinical studies.

The guidelines for inclusion developed in 

response to this law were published in the Federal 

Register in March 1994,7 and they have been fully

implemented. It is now the policy of NIH that 

women and members of minority groups and 
4

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

their subpopulations must be included in all 

NIH-supported biomedical and behavioral research

projects involving human subjects, unless a clear 

and compelling rationale and justification establishes that inclusion is inappropriate to the health 

of the subjects or the purpose of the research.

Working in collaboration with the Office of 

Extramural Research and other components of 

NIH, we have established a tracking system to 

monitor inclusion. Indeed, for the first time in 

NIH’s history, we are able to determine the numbers 

of women and minorities in clinical trials, and, we 

are now beginning to analyze data to establish trends 

in inclusion and determine better ways to examine

these data. Thus far, we have found high compliance

with inclusion policies.

The goal of NIH policy is not to satisfy any 

quotas for proportional representation, but rather to

conduct biomedical and behavioral research such that

the scientific knowledge acquired will be generalizable

to the entire population. In response to the tragedies 

of the PHS syphilis study in Tuskegee, Alabama, and

the effects on those exposed to DES and thalidomide 

in utero, regulations were put in place to protect

women, minorities, and other populations from 

being exploited in research. As we work to ensure

women’s appropriate inclusion in clinical studies, we

still must grapple with the very sensitive ethical and

legal issues of including women of childbearing age 

in such research. In addressing these issues, we must

weigh the risks of such participation to women and

their potential offspring against the benefits of participation in clinical studies.

A continued emphasis on the need for innovative and successful strategies to recruit women as 

volunteers in clinical research, including special 

populations of women across the life span, must

remain a consideration in research design. In fact, 

the implementation of the NIH policy for the inclusion of women and minorities in human subject

research requires the increased participation of 

women and minority physicians and scientists in 

the design, implementation, and interpretation 

of such studies.

Women in Biomedical Careers

With expanding horizons in science and biotechnology, greater participation by women as investigators

in studies to explore new frontiers of knowledge about

health, disease, and normative development in girls

and women is needed. While exact figures are not

available for those who are participating in research,

there is a need to increase not only the numbers of

women who are biomedical and behavioral investigators, but also the numbers of women who are in 

policy making positions and who can influence or

determine the direction of research initiatives.

To help us to determine the best ways to 

increase opportunities for women in biomedical

research careers, in 1992, ORWH convened a 

public hearing and workshop on the recruitment,

retention, advancement, and re-entry of women 

in biomedical careers. The goal was not only to 

identify barriers to women’s success, but also to 

devise strategies and programs to enable women 

to overcome those barriers.

At the 1992 meeting, a number of barriers 

were identified and published in a report, Women in

Biomedical Careers: Dynamics of Change — Strategies 

for the 21st Century.8 From nearly 70 testimonies, 

nine general issues that present barriers emerged.

These barriers are common to women in the biomedical professions, regardless of racial, ethnic, cultural,

socioeconomic, or other backgrounds. These are:

• Recruiting women to biomedical sciences

• Visibility, role models, and mentors

• Career paths and rewards

• Re-entry into a biomedical career

• Family responsibilities
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VOLUME 2

• Sexual discrimination and sexual harassment

• Research initiatives on women’s health

• Sensitizing men about special career concerns 

of women

• Minorities and racial discrimination.

Based on the findings and recommendations 

of that meeting, ORWH has initiated and sponsored 

a number of programs, including one that addresses

the loss to science of women who have interrupted

their research careers to fulfill familial responsibilities,

the Re-Entry Program for Biomedical Scientists. Started

as a pilot project in 1992, the re-entry program was

assessed under the leadership of Joyce Rudick and 

the cochairs of the Subcommittee on Biomedical

Careers of the NIH Coordinating Committee for

Research on Women’s Health, Dr. Anne Sassaman 

and Dr. Julia Freeman. The re-entry program has 

now been institutionalized across NIH. Since 

1992, participants in the program have published 

72 papers, with 43 re-entry scientists as the primary

author, in such journals as the Journal of Cell Science,

Biological Psychiatry, Molecular Microbiology, American Journal of Epidemiology, Journal of Biological 

Chemistry, American Journal of Psychiatry, Journal 

of Clinical Investigation, and Journal of the American Medical Association.

Ensuring that the findings derived from research

on women’s health are incorporated into the education and training of the next generation of health 

care providers is an important priority for ORWH. 

As a part of our effort to address the implementation 

of the NIH agenda on women’s health research and 

the role of such research in helping to establish

improved standards of health care practice that 

promote multidisciplinary, comprehensive, and 

effective women’s health care, we collaborated with 

the Health Resources and Services Administration

(HRSA) and the Public Health Service Office of

Women’s Health to prepare a report of surveys of 

all osteopathic and allopathic schools of medicine 

to determine women’s health in their curricula. 

The resulting report, Women’s Health in the Medical School Curriculum: Report of a Survey and Recommendations,9 also contains examples of curricula 

that incorporate women’s health issues. We are 

now working with the dental, nursing, and pharmacy representatives for a similar study of their 

educational curricula.

We have also put in place a number of other 

programs and initiatives to enhance participation of

women and men scientists in research on women’s

health. These include workshops on how to speak 

and write about science, as well as training projects

that provide opportunities for high school students,

college faculty and students, and minority students 

to obtain research experience or exposure to current

scientific concepts through NIH. ORWH has also

developed and supported a number of programs 

for the advancement of girls and women in science

through collaboration with the NIH Office of Science

Education. These programs included: outreach on 

the World Wide Web; a speakers bureau that allows 

a diverse group of women scientists in the NIH community to provide both role models and information

about careers in research; a very popular course

designed to teach young scientists to write about 

science effectively; a series of workshops to teach

young scientists how to present scientific data effectively; a program for the NIH summer interns that 

provides a forum for discussion of family and career

concerns that can affect their professional and personal lives; and a series of workshops to support the

successful career development of young postdoctoral

intramural researchers.

NIH National Research Agenda on 

Women’s Health

Progress has been made in establishing women’s

health research as an integral part of the fabric of 

NIH research and programs; but progress gives 

rise to new questions, a need for an assessment, 

consideration of new priorities, and a revitalized
6

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

research agenda. We believed that it was time to 

look “beyond Hunt Valley” and to update our agenda. 

Beginning in September 1996, ORWH convened 

a series of meetings, “Beyond Hunt Valley: Research 

on Women’s Health for the 21st Century,” to foster 

collaboration among representatives of the NIH community and the broader women’s health community 

to revise the research agenda on women’s health. In

planning these meetings, we turned to the model of 

the first Hunt Valley meeting where broad participation through public hearings and workshops proved 

so productive and fruitful. This mechanism has provided an opportunity for ongoing collaboration among

individuals and groups of women, advocates, scientists,

health care practitioners, and pubic health policymakers with NIH to establish our research agenda as we

move forward into the 21st century.

The original women’s health research agenda

developed as a result of the Hunt Valley meeting

embodied certain underlying principles that will 

continue to inform our directions for the future. 

The “Hunt Valley Report” redefined the parameters 

of women’s health to encompass research to better

understand sex and gender differences between 

women and men in development, health, and disease,

and to focus on populations of women that have been

under represented in clinical research in the past. This

agenda recognizes the full spectrum of research from

basic to clinical research and trials, epidemiological 

and population studies, clinical applications, and

health outcomes. We have embraced an expanded 

concept of women’s health and research that encompasses the health of girls and women across the life

span, from the prenatal stage to that of the frail elderly.

Most important, the agenda reflects the fact that

women’s health implies more than the reproductive

system. The agenda also emphasizes basic science

investigations, not just human subject research.

The research agenda includes biomedical as 

well as behavioral and psychosocial research, with 

a focus on multidisciplinary collaboration. It focuses 

on sex and gender factors in the health and diseases 

of women, in considering such matters as normal

development, disease prevention, health maintenance,

response to interventions, disease prognosis, and treatment outcomes. We have also focused on factors that

influence differences in health status and health outcomes among diverse populations of women. Moreover, priorities have been established for populations 

of women and girls that have been previously excluded

from scientific investigation, such as minorities, women

of low socioeconomic status and isolated geographic

locations, lesbians, and women with disabilities.

In all our efforts to implement our research 

agenda, ORWH participates in an active and beneficial partnership with all of the NIH institutes 

and centers. We continually review our research 

priorities to determine where the major gaps in 

knowledge exist.

At our first regional meeting, held September 

1996 in Philadelphia, where our hosts were the

Allegheny University of the Health Sciences and 

the University of Pennsylvania, we started to examine our research agenda to ensure its relevance 

as we move toward the next century. At the Philadelphia meeting, we directed attention to some of the

major areas of concern for women’s health. We later

looked at women’s health from two perspectives — 

sex and gender factors, as well as differences in health

among diverse populations of women. At the second

meeting, held in New Orleans, we examined aspects 

of the research agenda based upon sex and gender 

perspectives (i.e., physiological, psychosocial, and

pharmacologic differences between women and 

men). Plenary presentations addressed the role of 

hormones in sex and gender differences, as well as 

the role of the environment and genetic heritage. 

At our third regional meeting, held in Santa Fe, 

New Mexico, participants focused on factors that 

contribute to differences in health status and health

outcomes among diverse populations of women. 

These included biological, genetic, racial, cultural 
7

VOLUME 2

and ethnic, psychosocial and behavioral factors, 

educational influences, traditional and alternative

health practices, environmental influences, poverty 

and socioeconomic status, access to health care, 

and occupational issues. The plenary sessions also

included considerations of health issues for women

who have disabilities.

At the final, national meeting in the series, 

held in Bethesda, Maryland, in November 1997, we

addressed issues raised at the three regional meetings

and invited participants to consider additional issues 

to guide our Task Force in developing recommendations for the NIH research agenda on women’s health

for the 21st century. The specific objectives of this 

final workshop were to:

• Consider progress in knowledge about women’s

health through research;

• Determine continuing or emerging gaps in 

knowledge, and related issues and implications;

• Recommend a new framework for research priorities on women’s health, conditions and diseases;

• Recommend how these research initiatives can 

best be accomplished;

• Recommend ways to improve dissemination of

research outcomes, integration into health education, and implementation in health practices and

public policies.

• Recommend programs and collaborations to

increase opportunities for participation and

advancement of women in research careers.

We asked participants to consider the following:

• The original “Hunt Valley Report” recommendations

• Deliberations and recommendations from three

regional meetings

• Special populations of women

• Factors that affect different populations of women

• Sex and gender issues

• Normal processes, developmental biology, and aging

• Life span concepts

All the recommendations for our research agenda

must be based upon science driven initiatives. Thus,

the role of the participants was challenging, significant,

and meaningful. Our updated agenda must reaffirm 

the commitment to an integration of scientific disciplines and medical specialties with advocacy and 

forward-thinking optimism. The goal is to make a 

positive difference in women’s health in the 21st 

century through an improved research agenda 

that will yield scientific data to lessen or eliminate 

continuing or emerging gaps in knowledge about

women’s health.

Over the past decade, with the creation of 

new laws, policies, and programs, we have made 

tangible progress toward improving women’s health,

and we have gained a sure sense of our power to 

effect real change. With your assistance, as we enter 

the 21st century, the Office of Research on Women’s

Health can build on that progress and markedly

improve the health of women and their families. 

That is the vision for women’s health in the United

States and worldwide that we have entrusted the 

members of the Task Force and all participants in 

this process to help us ensure for the future. No 

single individual or group can do the job alone. 

The challenge — and the responsibility — must 

be shared by all of us.

References

1 U.S. Public Health Service. Women’s Health: Report 

of the Public Health Service Task Force on Women’s 

Health Issues. Vol. 1, no. 1 (January-February 1985) 1:76.

2 National Institutes of Health. Division of Research Grants.

NIH Guide for Grants and Contracts. January 23, 1987.

3 National Institutes of Health. Division of Research Grants.

NIH Guide to Grants and Contracts. September 25, 1987. 
8

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

4 Nadel, MV. National Institutes of Health: Problems in

Implementing Policy on Women in Study Populations.

Washington, D.C.: U.S. General Accounting Office, 

June 1990.

5 National Institutes of Health. Report of the National 

Institutes of Health: Opportunities for Research on

Women’s Health. NIH Pub. No. 92-3457. Bethesda, 

Md.: September 1992. 

6 National Institutes of Health Revitalization Act of 1993

(Public Law 103-43), 107, Stat. 22 (codified at 42 U.S.C.

289.a-1), June 10, 1993, at 486(d) (4) (D). 

7 U.S. Department of Health and Human Services. 

National Institutes of Health. NIH Guidelines on the 

Inclusion of Women and Minorities as Subjects in 

Clinical Research; Notice. Federal Register, 59:14508-

15413 (March 28, 1994).

8 National Institutes of Health. Women in Biomedical

Careers: Dynamics of Change. NIH Pub. No. 95-3565A.

Bethesda, Md.: 1994.

9 Sumaya CV, Pinn VW, Blumenthal SJ. Women’s Health 

in the Medical School Curriculum: Report of a Survey 

and Recommendations. Health Resources and Services

Administration, National Institutes of Heath, Department

of Health and Human Services, 1996.
9

VOLUME 2

The 7 years since the Office of Research on

Women’s Health’s (ORWH) original report 

on the health needs of women have witnessed

a remarkable expansion of interest in the female

patient. In a very real sense, that interest is the result 

of the expanding competence and power of women

that began with World War II. This global catastrophe

facilitated women’s entries into positions and professions that had been previously almost exclusively 

available to men. The emergence of feminism in the

1950s was an inevitable consequence of women’s 

new sense of what was possible for them to achieve 

on their own rather than through alliances with 

powerful men: access to the professions and to their

own money, and with it, increasing immediate control

over the world around them. Feminism was bred of

women’s new and expanded sense of their identities 

as individuals beyond their traditional roles of wife 

and mother, and of what they were due from a society

that held them as less valuable than men. Their interest

in social justice and appropriate access to the options

available within the life of the community extended 

to a consideration of their health needs. 

Women’s increasing ability to call attention to 

their needs gained strength in the decades after 

World War II and was reflected first in the 1985 

report of the U.S. Public Health Service’s Task Force 

on Women’s Health Issues, which concluded that

women’s health care was compromised by the lack 

of research focus on women’s health concerns. By

1986, the National Institutes of Health (NIH) urged

that research protocols include appropriate numbers 

of female subjects wherever relevant, although the

1990 report of the General Accounting Office (GAO)

indicated that because of a lack of aggregate or 

NIH-wide record keeping, it was unable to monitor 

NIH’s performance on ensuring that this was 

accomplished. This report and other pressures for 

more attention prompted the NIH Revitalization 

Act of 1993, which stated the condition that any 

NIH-supported research must include appropriate

numbers of subpopulations (including women) 

in the cohort of subjects studied. Cost was not a 

justification for failure to do this. In 1990, the Congressional Caucus for Women’s Issues introduced 

22 bills to Congress that addressed research, care, 

and prevention issues in women’s health. Six of the

research-related provisions were incorporated into 

the 1991-1992 NIH Revitalization Act, which became

law in 1993 and gave statutory authorization to

ORWH. The Food and Drug Administration (FDA) 

was not exempt from the sweeping reforms. In 1992,

the FDA cosponsored a conference with the Food 

and Drug Law Institute to debate issues of including

women in clinical trials of FDA-regulated products.

The GAO released a report examining the FDA’s 

policies and the pharmaceutical industry’s practices

regarding drug testing and women and concluded 

that for more than 60 percent of the drugs, the representation of women in the test population was less 

than the representation of women in the population

with the corresponding disease. The worst case, 

ironically, was in the area of cardiovascular disease,

where companies were frequently failing to analyze 

or collect data for gender differences in response to

drugs. By 1993, the FDA lifted its 1977 edict that

reproductive-age women should be isolated from 

clinical research and recommended that data be 

analyzed as a function of gender.

Women have demanded that we learn more 

about the normal physiology of females and of 

the unique ways in which they experience disease.

O VERVIEW AND 

P E R S P E CTIVES

O F THE TASK

FORCE COCHAIRS

Marianne Legato, M.D., F.A.C.P.

Professor of Clinical Medicine

Columbia University College of 

Physicians and Surgeons

Donna Dean, Ph.D. 

Senior Advisor to the Deputy Director

National Institutes of Health
10

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

They want to be included in clinical investigation, they

want federal monies devoted to their health needs 

and they have been entering medical and other health

professional schools in increasing numbers. Clinical

researchers have concentrated on exposing, publicizing,

and correcting gender prejudice in health care delivery

to women. The results have been mixed, but women

have achieved some progress. A notable example is the

Women’s Health Initiative (WHI), an unprecedented

prospective $625,000,000 study on 165,000 women 

of diverse racial and ethnic backgrounds between 

the ages of 50 and 79 years of age in large and small

communities nationwide. Over the past few years,

ORWH has flourished, using its resources to focus 

on and publicize women’s health needs, to support

research that concentrates on women, and to ensure

ways to encourage the entry into and retention of

women in research careers.

This Task Force had several fundamental questions about women’s health, some of which had been

addressed by the Institute of Medicine’s Committee 

on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies.1 Because of the 

lack of a tracking system to monitor inclusion in 1990,

that Committee had difficulty, in fact, in demonstrating

that women had been understudied or excluded from

research. Nevertheless, the report made it clear that

investigators frequently did not report the results of

data analyzed by sex/gender, did not perform any

sex/gender analyses of study results, and did not 

recruit adequate numbers of women to support 

conclusions regarding the impact of sex/gender 

on the observations made. 

Several fundamental questions arise, some of

which have not yet been satisfactorily answered.

• Has the exclusion of women from clinical 

research affected their health?

We are just beginning to understand and appreciate the differences between men and women in virtually every system of the body, as well as in the way men

and women experience disease. Differences in drug

metabolism frequently explain women’s vulnerability 

to medications which have been tested primarily 

in men. For example, one study reports that the 

treatment of mild to moderate hypertension in white

women increased the all-cause death rate by 26 percent, while lowering all-cause mortality in men by 

15 percent.2 Another study (SWORD trial on sotalol 

in the treatment of postmyocardial infarction arrhythmias) was discontinued because of the increase in 

mortality of the women in the trial.3

• Can research on men be extrapolated to women

without modification?

Investigators consistently assume that information they glean from clinical and basic studies on 

male subjects can be extrapolated without modification to women. This traditional assumption was 

rarely, if ever, directly tested. It is remarkable that 

we have tolerated this “leap of faith” in an otherwise

rigorous research enterprise. In no other area have 

we permitted unproven assumptions to be accepted 

as fact. We now have enough information about the

differences between males and females to acknowledge the danger of assuming that they are identical. 

An excellent example is the way in which men and

women respond to drugs: The working group on 

pharmacologic issues has highlighted the differences

between men and women in the cytochrome P450 system and the unique role of hormones in drug effects.

• Do government mandated research guidelines 

to include women restrict the scientific community so severely that they compromise the 

quality and amount of investigation done? 

What does it cost to include women in clinical

investigation? If it is more, will the result be 

fewer clinical trials and studies? If so, what 

will be the impact on the health of the public?

Some diseases occur more frequently in men 

than in women, or during a quite different age or

developmental period. Those factors, as well as the 

difficulty in recruiting premenopausal women, have

been cited as impeding clinical investigations that

include both males and females. The scientific community has defended its reluctance to study women
11

VOLUME 2

directly on the basis of the relatively more constant

physiologic state of males. Complicating the issue is 

the cyclic variability of women of reproductive age.

Including younger females in clinical trial populations

would necessitate larger and, therefore, more costly

investigations. Regardless of the assertion that cost

should not be an obstacle to creating an adequate 

and accurate protocol, these economic, ethical/moral,

and intellectual issues need public debate and clear

guidelines. The assumption that studies on men are

“good enough” for women, based on the premise that

to be human is a homogeneous condition, is flawed.

We have not, however, acknowledged the fact that 

so far, our attention has been concentrated on postmenopausal women in the major studies devoted 

to the female patient (e.g., the Postmenopausal Estrogen/Progesterone Intervention (PEPI) study and the

WHI). The unique needs of the premenopausal 

and pregnant woman must be considered as well. 

The vulnerability of the premenopausal woman, 

particularly if she is pregnant, has often been cited 

as a reason for exclusion from clinical studies and 

trials of younger females. This general policy of 

protectionism, codified in PHS regulations promulgated by the Office for Protection from Research 

Risks (OPRR)4 characterized FDA and NIH standards

for clinical trial populations from the 1970s until 

the late 1980s. As a direct result, we have been left

ignorant of much essential first-hand information 

about the female patient and her unique responses 

to therapeutic interventions developed in studies 

carried out exclusively in men.

The issue of how to describe differences in 

health status or outcomes between men and women 

is fraught with conceptual difficulty. Should differences — for example in rates of heart disease, participation in research, or access to specialty services

— be attributed to “sex” or to “gender?” Are the two 

terms equivalent, or do they describe conceptually 

distinct approaches to understanding difference? 

Unfortunately, the language of difference in the biomedical literature is often imprecise, conflating the 

two terms, treating them as virtual synonyms. This

imprecise use of language presented difficulty to the

Beyond Hunt Valley working groups and Task Force

and remains a challenge.

Hence, we wish to acknowledge the significance 

of the conceptual distinction for women’s health. The

Task Force in no way wishes to imply that straightforward biological difference, such as that associated with

the action of a particular sex hormone, is an adequate

explanatory model for research on health differences

between men and women. Since confusion is the order

of the day throughout the biomedical literature, it is

impossible within the confines of this report to offer 

a definitive clarification. Readers will note that authors

differ in their use of the terms, with some maintaining

a clear distinction between biological versus social or

cultural elements of difference and others using the

terms as virtual synonyms. Ideally, a women’s health

research agenda would recognize the need for studies

on all aspects of differences between men and women,

maintaining the conceptual clarity necessary for high

quality research. During the next 5 years, ORWH will

take on that challenge as well. An excellent conceptual

framework is presented in the following chapter on 

the use of sex and gender terminology.

BASIS OF REPORT 

RECOMMENDATIONS

The chapters of this report present the recommendations of the 1997-1998 Task Force for Beyond

Hunt Valley: Research on Women’s Health for the 21st

Century, appointed by ORWH to determine the most

fruitful and useful directions for medical research conducted by NIH on women during the next 5 years.

Current NIH Research of Particular Importance 

to Women

Mindful of the rich and varied portfolio of research

efforts already supported by NIH, the Task Force first

reviewed current NIH-supported activities and research

of particular importance for women. Some examples of

major ongoing investigations at NIH are as follows:

1. Neurosciences/brain biology. Given the sexual 

dimorphism in the structure and function of 
12

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

the human brain, as well as in the incidence 

of degenerative and affective diseases of the brain,

the following areas of ongoing research promise 

to be particularly useful for women: (a) the development and degeneration of neurons; (b) the therapeutic effects of St. John’s Wort; (c) the nature of

pain; (d) behavioral research on obesity and substance addiction (including smoking); (e) development of new drugs for the treatment of alcoholism

and drug addiction; and (f) the brain molecular

anatomy project, which studies the patterns of

gene expression and the role of single genes in

brain function of mice with altered genomes.

2. Cardiovascular disease. The phenomenon of 

why many aspects of the risk factors for, clinical

presentation of, testing modalities of, therapeutic

choices of, and outcomes of cardiovascular disease

are different for men and women has been extensively explored by cardiovascular experts over the

past decade. The following gender-specific studies

are of particular interest to women: (a) the role 

of hypertension in accelerating vascular disease; 

(b) the role of plaque in atherosclerosis and mechanism of how it is formed; and (c) the role of genes

in progression and experience of diseases of the

heart and blood vessels, particularly regarding 

the involvement of other organs.

3. Asthma. The prevalence of asthma in women, 

particularly in Hispanic females, makes it a disease

of particular interest to clinicians interested in

treating the female patient. Clinical trials to prevent environmentally induced asthma in children

are of special interest to women. The prevention 

of asthma in children is an area of heavy concentration at NIH, particularly the prevention of 

morbidity and mortality by monitoring trends 

and risk factors for this disease.

4. Infectious diseases. Infectious and parasitic diseases

still claim more lives than any other disease category in the world. Research relevant to women

includes (a) the search for novel approaches for 

the treatment of infectious diseases, particularly

tropical and viral diseases, tuberculosis, and 

hepatitis C; and (b) work on the genome of the

HIV virus, which has offered expanding promise

for development of effective therapy and serves 

as a model of how genetic information may help

defeat disease.

5. Diabetes. Diabetes poses particular problems 

for women, not the least of which is the four- to

sixfold increase in vulnerability of the diabetic

woman, regardless of age and menopausal status,

to coronary artery diseases. Hence, the following

investigations are of particular importance: (a) the

role of nutrition and obesity in the pathogenesis 

of diabetes; (b) efforts to effect the regeneration 

of insulin producing cells; (c) the development 

of enhanced methods for drug delivery; and 

(4) research into the pathogenesis of the various

types of diabetes.

6. Women’s Health Initiative. The Women’s Health 

Initiative (WHI), one of the largest primary prevention studies in postmenopausal women, 

50 to 79 years of age, in the United States, has 

three components: (1) a randomized controlled

clinical trial (67,000 participants) which will 

evaluate the effect of a low-fat diet on prevention 

of breast and colon cancer and coronary heart 

disease, examine the effect of hormone replacement therapy on prevention of coronary heart 

disease and osteoporotic fractures, and evaluate 

the effect of calcium and vitamin D supplementation on prevention of osteoporotic fractures and

colon cancer, (2) an observational study (100,000

participants) that will delineate new risk factors

and biological markers in women and identify 

predictors of disease, and (3) a community prevention study, (20,000 participants) conducted

with the Centers for Disease Control and Prevention, to evaluate strategies for the adoption 

of healthful behaviors including improved diet,

nutritional supplementation, smoking cessation,

increased physical activity, and early detection 

of diseases for women of diverse races, ethnic

groups, and socioeconomic strata. The WHI will
13

VOLUME 2

provide important, scientifically valid information

for women, their health care providers, and their

communities. This information will reflect the benefits and risks of preventive approaches and the

means of achieving adoption of these behaviors. 

7. Other fundamental investigations. Studies on the 

following are of particular relevance to women: 

• The genes involved in producing long QT 

syndrome, a risk factor for cardiac arrest, 

and the genes essential for bone formation 

in a mouse animal model have been identified.

The latter is particularly useful in studying 

how to induce new bone development in

patients with osteoporosis or injury.

• Visualization of the brain in action with 

neuroimaging techniques. 

• New categories of drugs to treat depression. 

• The role of abnormal cell death and abnormal

cell reproduction in disease. Telomere length

determines whether or not a cell will divide;

disruptions in telomere function may explain

abnormal cell division or premature aging. 

• Drugs blocking angiogenesis in tumors.

• Factors governing metal transmembrane flux.

These studies will aid treatment of anemia 

and elucidate the mechanisms and usefulness

of inflammation and processes of cell repair. 

• Antimalarial drugs aimed at destroying 

the three proteins necessary for malarial 

parasite development.

8. New and advanced technologies. Laser capture

microdissection, a technique of isolating individual cells from tissue, may lead to the earlier 

diagnosis of malignancies. Other technologies 

relevant to women’s health include: GenBank, 

a central repository for genetic information; 

the Cancer Genome Anatomy project, which 

identifies molecular fingerprints of genes turned 

on during the development of cancers; and new

ways to deliver drugs previously available only 

by injection.

9. Outreach to special populations. Many outreach 

programs to minority populations are actively

underway, including special programs promoting cardiovascular health for Latinos, and in treatment of hypertension and dyslipidemia for blacks.

Inducements to increase the interest of women 

and under represented minorities in research

careers are under way as part of NIH’s increasing efforts in outreach to minority groups for

careers in science.

The Task Force based the research recommendations provided in these reports on the conclusions

reached by the working groups at the four scientific

symposia. The report recommendations go well 

beyond the above NIH research topics to incorporate

the concerns of the Task Force and the working 

groups about other aspects of women’s health. 

Overarching Issues

Despite their wide scope, the scientific reports

herein reveal several overarching themes.

• “Women’s health” is expanding into the larger 

concept of gender-specific medicine. Women’s

health is no longer an isolated phenomenon,

divorced from mainstream medicine and regarded

as a political or feminist issue. Instead, thoughtful

scientists now see women as important sources 

of new information that will correct essentially

male models of normal function and the pathophysiology of disease.

• The changing needs of women over the course 

of the life span are a common theme in most of 

the reports. Research on women’s health must

include the full biological life cycle of the woman

and the concomitant physical, mental, and emotional changes that occur. This concept was made

particularly clear at the ORWH regional scientific

workshops in Santa Fe, which addressed health
14

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

issues as they relate to women at all stages of life —

prenatally, during infancy and childhood, adolescence, reproductive and middle years, peri- and

postmenopausal years, and the elder years.

• Multidisciplinary research is essential. Such

research might be conducted under models like

that of the program project grant, and involve

teams of investigators with expertise in fields 

ranging from molecular biology to sociology 

and anthropology. It is suggested that the best

results will come from a team in which each 

member is convinced of the intrinsic value of

working together rather than working individually to address an issue or question of interest 

to all. Practically speaking, this will not be easy 

to achieve in academic medicine.

• The importance of social and behavioral science 

to research on women’s health is unquestionable.

Nevertheless, social and behavioral science needs

to communicate the principles of its discipline 

to the longer-established and more “mainstream”

medical disciplines. It is not now a familiar

resource or partner for conventional research.

• Most clinical studies have been performed in 

men, and virtually all reports urge the collection 

of first hand information from women to correct

male models of normal function and of the 

pathophysiology of disease.

Strengths of the Subcommittee Reports

One of the highlights of these reports is the

increased appreciation for the importance of racial, 

cultural, and gender diversity in research populations.

The rich suggestions for future research paths provided in the immunology and bone/musculoskeletal

diseases reports are another strength. Other reports,

particularly those addressing cardiovascular diseases

and cancer, are well on their way to realizing new and

particularly innovative programs that will advance not

only women’s health, but gender-specific biology. The

pharmacology report provides an excellent review of

the status of our understanding of gender-specific 

differences in drug metabolism in any given medical

field. This report makes a persuasive case for assessing

the impact of gender on normal human physiology.

The value of the public testimony (an innovative

feature of these symposia) is indisputable. We learned

things that otherwise would not have been heard, and

the lay public and advocacy groups became involved 

in important dialogues with the scientific community. 

This report is the culmination of a 2-year intensive effort on the part of more than 1,500 individuals

nationwide, reflecting a broad spectrum of interests

and expertise in women’s health. Under the guidance 

of the Task Force members and working group

Cochairs, a diverse array of participants evaluated

progress made, identified critical gaps in knowledge,

and formulated cogent recommendations for future

directions in research. We recognize that this massive

effort, although not perfect, has laid the key groundwork from which fruitful partnerships will evolve 

over the next millennium in women’s health research.

References

1 Mastroianni AC, Faden R, Federman D, editors. Women

and health research. Ethical and legal issues of including

women in clinical studies. Volume I. Division of Health

Sciences Policy, Institute of Medicine. Washington, D.C.: 

National Academy Press; 1994. 

2 Anastos K, Charney P, Charon RA et al. Hypertension 

in women: what is really known? The Women’s Caucus,

Working Group on Women’s Health of the Society of 

General Internal Medicine. Ann Intern Med 1991;

115:287.

3 Lehman MH, Hardy S, Archibald D, Quart B, MacNeil DJ.

Sex difference in risk of torsade de pointes with d,l-sotalol.

Circulation 1996;94:1535-41.

4 Office for Protection from Research Risks. Protection 

of Human Subjects, 45 CFR 46, Subpart B, Additional 

Protections Pertaining to Research Development, and

Related Activities Involving Fetuses, Pregnant Women, 

and Human In Vitro Fertilization. March 8, 1983.
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VOLUME 2

T H E U S E O F “S E X” A N D

“ G E N D E R” T O D E F I N E

AND CHARACTERIZE

MEANINGFUL DIFFERENCES BETWEEN MEN

AND WOMEN

INTRODUCTION

The issue of how to describe differences in

health status, or in the etiology, progress, 

and treatment of disease between men and

women, is fraught with lexical and conceptual difficulty. Should differences — for example in rates of 

heart disease, participation in research, adherence to

treatment, or access to specialty services — be attributed to “sex” or to “gender?” In the social sciences, 

the two terms usually describe conceptually distinct

approaches to understanding difference, “sex” denoting

biologically based differences and “gender” indicating

culturally shaped variations between men and women 

(or between notions of masculinity and femininity). 

Unfortunately, the language of difference in 

the biomedical literature is often imprecise, conflating

the two terms and treating them as virtual synonyms.

This imprecise use is not only linguistically problematic but has serious implications for future research,

clinical practice and treatment, as well as our very

understanding of the nature of the health outcomes

and status differences that we are studying. Without a

strong conceptual and theoretical understanding of the

distinction originally intended by those who clarified 

the difference between sex and gender, confusions 

are replicated. Choosing one term over another may

seem like an innocent matter of semantics; however,

the effects of such language choices and the meanings

that they carry with them have had a significant impact

on the equitable treatment of women in biomedical

research and clinical practice. We must be able to

define difference to take into account states of wellness and disease that women share with men and 

those that they do not. As the research agenda presented in this volume is implemented, a sophisticated

lexicon of difference will be essential to ensure the 

just treatment of women.

THE SEX/GENDER 

DISTINCTION

To understand the tenets of the sex/gender debate

and its effects on current concerns in women’s health,

one must first review the origins of the lexicon itself.

The original distinction between “sex” and “gender”

emerged in the mid-20th century. Feminist (and other)

scholars distinguished between those qualities conventionally attributed to biologically based differences

about a person’s “sex,” male or female, and those qualities that were understood as the result of cultural and

social processes that constitute a person as man or

woman: one’s “gender.”1-9

This distinction was one part of the challenge 

to the dominant beliefs of the late 19th and early 

20th centuries, which held that difference was biologically determined and that women’s constitutions were

more biologically driven than those of men.10 A similar challenge was made to the notions of biologically

determined racial characteristics attributed to African

Americans and others, which allegedly accounted for

differences in affect, intelligence, and economic status.

Over the past 25 years, use of the sex/gender distinction and lexicon has been fairly widespread throughout

Jennifer R. Fishman, B.S. 

Janis G. Wick, M.A.

Barbara A. Koenig, Ph.D.

Stanford University Center for Biomedical Ethics
16

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

both the social sciences and the humanities. In fact,

more often than not, “gender” is used in these fields 

to describe differences between men and women to

emphasize the idea that differences cannot merely 

be attributed to biological or physiological processes, 

but rather are almost always influenced by cultural,

social, and historical contexts.

SEX AND GENDER 

IN BIOMEDICAL 

LITERATURE

By contrast, in the biomedical sciences the 

distinction between “sex” and “gender” has been 

almost uniformly ignored. In fact, a quick glance at 

any database of medical literature reveals that not 

only are the terms “sex” and “gender” used synonymously, but that “gender” is often used instead of 

“sex” for describing biological factors, presumably

because it is considered more “politically correct” 

to do so.11,12 This conflation is common in popular

culture as well. However, in light of the history of the

emergence of “gender” as a conceptual framework, 

the imprecise and oftentimes careless usage of “gender”

in the biomedical literature leads to misinterpretation

and imbues the reported research results with unintended meanings. At the very least, the use of the term gender implies an acknowledgment and recognition of 

the sex/gender distinction, and, at most, it implies 

the understanding that “sex difference” is the result 

of complex arrangements between “biology” (e.g.,

genetics, hormones, physiology) and “culture” (e.g.,

hierarchical relationships, historical and geographical

location, social interactions). Yet this implicit meaning

often belies the results themselves, for they reveal that

no such understanding is intended. For example, a

recent conference entitled “Gender Differences in Pain”

actually focused exclusively on biological differences

between men and women, and therefore might have

more correctly been titled “Sex Differences in Pain.”

Inclusion of “gender” in the title implies an understanding of the social and cultural components of 

sex differences in pain perceptions, and, in particular,

would include discussions of the well established and

recognized observations of the culturally and socially

embedded assumptions that physicians make that

women, as opposed to men, overestimate and inflate

their painful symptoms.13 However, these topics were

not discussed at the meeting, which instead focused

solely on the biological determinants of pain perception. The conference title, striving for political correctness, yielded only mystification.

This confusion is exemplified by recurrent 

debates in the “letters to the editor” sections of 

many medical journals. In the Journal of the American

Medical Association, a letter under the heading “The

Eternal Battle of Sex vs Gender” expressed the author’s

distress that in the “Instructions for Preparing Structured Abstracts” that “gender” was used instead 

of “sex.” However, the complaint was issued not

because the author felt that “gender” implied something in particular about sex differences that should 

be considered, but rather that “gender” should be

reserved as a grammatical term referring to the masculinity or femininity of nouns (as in most Romance

languages). In other words, nouns can have a gender;

people only have a sex. The editor’s response is equally

revealing: while citing various sources for definitions 

of gender she concludes that the “evolving nature of

the word gender causes some fuzzy usage . . . [perhaps

the time is ripe for a book on One Hundred and One

Things You Wanted to Know About Gender and Were

Not Afraid to Ask.”15 Although this letter was published in 1991, the confusion and uncertainty in 

medical journal publishing persists. One correspondent argues that the use of gender in scientific writing

as anything other than the grammatical classification 

of a noun is improper use and “unpardonable.”16

Echoing this sentiment, the New England Journal 

of Medicine asked an author to “correct” the title of 

his paper on gender differences in health insurance, 

as the editors felt that the word “gender” referred 

only to the grammatical case of foreign nouns.17

The unwillingness of biomedical journals to consider other uses and meanings of “gender” exacerbates the confusion over the matter, as the term 

continues to be used both within and outside of 

biomedical literature.
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VOLUME 2

NEW DIRECTIONS 

IN THE DEBATE

To further complicate matters, social scientific

research on the sex/gender distinction continues to

reveal the ways in which this distinction itself does 

not reflect the complex relationship between or meanings of both sex and gender. Thus, while biomedical

discourse has not even grappled with the original 

lexicon of sex and gender, the sex/gender debate in 

the social sciences continues to move in new directions, leaving biomedicine further behind. One such

direction is the way in which the designation of “biological sex“ itself as a binary concept of male versus

female ignores the realities of both biology and sex.

Social scientists argue that the category “biological 

sex” is a complex arena in which a variety of genetic,

metabolic, and hormonal factors create individuals 

for whom a sex is socially assigned. Although one’s 

sex is most often determined by one’s genotype (i.e.,

XX or XY chromosomes), some scholars argue that 

the binary assignment is itself a cultural construct, 

and perhaps it is more appropriate to classify sex on 

a continuum, or at least a categorical system that

includes more than two categories.18-20 Still other

scholars study the fairly arbitrary assignment of sex

that is made for individuals for whom no specific “sex”

(read: male or female) assignment is possible due to

physical ambiguities.19,21-23 In developed countries,

such arbitrary assignment is often accompanied by 

genital surgery to “fix” any uncertainty in the child’s

visible sex. These cases beg the question of what is “sex.” 

Our understanding of the sexed body, particularly the female body, and the aspects of it which 

are deemed biologically “determined” has actually 

shifted substantially in the last century. In the late 

19th century, biologically determined “femaleness” 

was thought to be localized in a particular organ, 

first the uterus and then the ovaries.24-26 In the 

early 20th century, the locus of the biologically 

determined “essence” of “femaleness” was viewed 

as hormonal. In fact, a hormonal conception of the

body is now one of the dominant ways of thinking

about the biological roots of sex differences.18,27

Certainly the interest of biomedicine in the 

hormonal bases for health and disease in women 

is critically important, particularly in light of recent

research on the potential protective benefits of estrogen against heart disease, the popularity of both birth

control pills and hormone replacement therapies, 

and the increase in use of hormones in infertility 

treatments. However, attention to the hormonal 

bases of health and disease to the exclusion of other

contributing factors in women continues to relegate

women’s health to narrow biological definitions.

In addition, we are facing the possibility of yet

another return to biological determinism with the

emerging dominance of genetic models of disease causation within biomedicine. Already in many ways, the

female (and male) body is a “genetic” body: her sex is

determined most definitively by her genetic sex or genotype. It is certainly the case that many are attempting

to define disease states based on genotype. Studies are

underway to locate genetic components of breast cancer, alcoholism, Alzheimer disease, and many others.

This trend may have distinctive consequences for women’s

health as the new genomics may serve as a paradigm

for biologically determined “femaleness” as well.

The nature of the relationship between sex and

gender has also been examined by social scientists who

argue that our notions of the ways that gender “maps

onto” sex may be simplistic and neglect the diversity of

experiences of both men and women. Although there is

the desire to separate that which is biologically determined about sex differences and that which is social,

cultural, and environmental, scholars have since argued

that neither sex nor gender — nor the relationship

between “sex” and “gender” — can be understood so

simplistically. However to lump everything into either

the “sex” or “gender” category, depending on your political or disciplinary persuasion, is equally problematic,

for one’s linguistic decision implies assumptions about

the nature of difference. As a result, feminist scholars

have been attempting to move past the sex/gender distinction without neglecting or dismissing the pull of

biological determinism whenever discussing sex or the

complex “real life” experiences of men and women.
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

EQUITABLE AND JUST

TREATMENT FOR WOMEN

The lack of an appropriate lexicon of sex difference in biomedicine has had a serious impact on the

just and equitable treatment of women in biomedical

research and clinical medicine. The ambiguity and 

confusion about appropriate language speaks of a 

larger ethical problem of how it is that sex difference

has been conceived, studied, and addressed in biomedicine. Our understanding of the nature, importance,

and implications of sex difference is growing, as should

our understanding of the complexities and dilemmas 

of researching and reporting such differences. It was

not long ago that women were routinely excluded from

large-scale clinical trials. For instance, most trials for

the prevention of heart disease studied middle-aged

males and excluded women because of a complex set

of assumptions, including the perception that women’s

hearts were the same as men’s. In this case an assumption of sameness led to unethical and neglectful treatment of women.28–30 Yet, one of the reasons women

were not included in these trials is because of the perception that women’s bodies (hormonally and reproductively) behaved very differently than men’s and that

these factors would complicate the collection of safe

and reliable data. Therefore, women were enough like

men to warrant exclusion from clinical studies, yet,

they were too different to be included as part of the

same study. This confusing and paradoxical attitude

towards sex difference in clinical trials demonstrates

the complexities and problems attending to sex difference. The human subjects guidelines have changed to

require the inclusion of women in clinical trials, yet the

question remains of how similarities and differences

between men and women will be explored, studied,

and compared.28–32

In some cases of biomedical research and clinical

treatment, sex difference is not explicitly attended 

to, yet its implications lie just below the surface. 

An example of this phenomenon is the treatment for

women with depression. Although we have sufficiently

documented the higher proportion of women than 

men who are medically treated for depression, we 

have not turned our attention to the implications of

this difference.33 It is here that the sex/gender debate

may well be able to provide a backdrop for studying

this observed difference. In other words, does noting

this difference between men and women unknowingly

imply that the difference can be attributed to biological

factors? Are women at “higher risk” for depression 

simply by virtue of being female? We can hypothesize

many explanatory models for this observation, ranging

from biological and hormonal factors that predispose

women to depression to a “cultural” model that would

explore the mental health consequences of sociocultural stratification, including women’s greater tendencies

to seek medical care, in concert with physicians’ tendencies to pathologize women’s mental health problems.34,35 The model we hypothesize depends on our

perceptions and conceptualization of the nature of sex

difference itself; leaving that conceptual base unexamined is dangerous for women’s health and women’s

health research. It is also of potential harm to men.

Pfeffer (1985) argues that men’s reproductive health

problems have conventionally been treated similarly 

to women’s health problems, that is, pathologized.36

Accompanying the conceptual difficulties associated with the lack of an appropriate lexicon of difference is an inability to explore underlying causes of

“women’s” diseases. The effects of this inability on treatment are enormous. One example is the way in which

tranquilizers have been prescribed to large numbers of

women, based on the assumption that such drugs are

“safe” and “non-addictive,” and that women must be

“naturally” more nervous and anxious than men. The

treatments offered women in these cases, most often

prescription drugs, have been unnecessarily limited

due to a lack of conceptual understanding of the underlying causes for the differences in women’s experiences.

A further ethical concern stems from the recurrent debates about “nature” versus “nurture” that have

become an inherent part of the emergence of the biotechnologies of genetic testing. With the Human

Genome Project more than halfway complete, biomedical researchers and clinicians face questions daily about

what exactly is biologically determined and what can
19

VOLUME 2

be attributed to “environment,” or perhaps the even

harder question of how do genes (or one’s biological

make-up) interact with one’s environment? Sex differences become part of this complex set of questions: in

the same way that we must look at the complex interplay between “biology” and “culture” to understand

disease causation, prognosis, and treatment options, 

we must also look at the differences between men and

women. Ethically, this is a difficult task. In the case of

the new biotechnologies that allow for genetic testing

for susceptibility to disease, the ethical implications of

developing, offering, or performing such tests are enormous. If we offer someone a genetic test for a disease

that cannot be prevented or cured, are we offering

patients meaningful choices? This is equally true for

questions about the nature of sex difference. To assume

that the differences in health status or outcomes between

men and women is biological leaves us a restricted 

set of choices for research and treatment. If we do not

explore the complex relationship between “nature” and

“nurture” how can we conduct appropriate research

into health and disease in women and treat them fairly?

The use of an imprecise lexicon for describing 

differences between men and women in biomedical

research has consequences for the conduct of science 

as well as for the clinical treatment of women. In each

of the above examples, and in numerous others, the

use of categories of “men” and “women” for describing

difference assumes that the differences between the two

categories are greater than differences within the two

groups.10 By relying on sex category differences as the

primary marker of difference other potentially important factors may be ignored, for example the complex

interaction of race, sex, and social class within our health

care system.10 This case has been effectively made for

the social category of race, where both the ethics and

the science of research based on differences between

racial categories has been questioned.10,37,38 Within

biomedical research that studies racial difference, there

is often the implicit assumption that the differences between racial groups are biologically based or genetically

determined. Yet many have problematized this assumption, pointing out the ways in which there are often

larger differences within categories than between them.

Moreover, documenting differences based on supposedly categorical differences between races within biomedicine not only assumes that such differences are

somehow inherent to those within that racial category,

but also has the potential to stigmatize and blame those

considered within that category for falling ill. This affects

clinical visits and treatment options for such individuals. Assumptions about categorical differences between

the sexes is no different, and should be held equally

suspect. Indeed, both “race” and “sex” characterizations

have often been used not for delineating important 

differences in terms of treatment but for underlying

political and cultural reasons which have proved highly

detrimental to both women and racially stigmatized

groups. Developing a precise lexicon of sex difference

would be a primary step away from such deleterious

distinctions, for it demands that we focus on the ways

in which we measure and report differences between

men and women, and most importantly allows us to

specify what these differences mean for biomedical

research and ultimately for patients in clinical settings.

The authors wish to thank Adele E. Clarke and 

Nancy Fugate Woods for helpful comments on earlier 

drafts of this manuscript.

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8 Rosaldo M, Lamphere L, eds. Women, Culture, and 

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9 Unger RK. Toward a redefinition of sex and gender. 

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13 Heston TF, Lewis LM. Gender bias in the evaluation 

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N Engl J Med 1997; 336:218-21.

18 Clarke AE. Disciplining Reproduction: Modernity, 

American Life Sciences, and the Problems of Sex.

Berkeley: University of California, 1998.

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scientific chapters

ALCOHOL, TOBACCO,

AND OTHER DRUG USE,

DISORDERS, AND 

CONSEQUENCES

BACKGROUND

The association between mental health and 

alcohol and other drug use was addressed 

during public hearings and workshop proceedings at the regional workshop, “Beyond Hunt 

Valley: Research on Women’s Health for the 21st 

Century,” held in Philadelphia, Pennsylvania. The

report that resulted from these activities contains 

a summary of recent findings related to body and 

mind including addictive disorders and a series 

of research recommendations. 

For the “Beyond Hunt Valley” national workshop

held in Bethesda, Maryland, ORWH recommended

development of independent reports on mental health

and alcohol, tobacco, and other drug use to ensure a

wider range of discussion. This resulted in the formation of two working groups: (a) Mental Disorders and

(b) Alcohol, Tobacco, and Other Drug Use, Disorders,

and Consequences.

The study of women’s health has been formalized through the efforts of ORWH. Inclusion of 

women and minorities in study populations has

increased research attention on issues related to 

alcohol and drug use among these groups. Clinical

studies now use research designs that include the

development of more sensitive data collection instruments. Furthermore, women are recognized as a 

heterogeneous group. Research has expanded to 

examine life span and lifestyle issues. Studies have

been encouraged that focus on alcohol and drug 

use among postmenopausal women, lesbians, 

pregnant women, women with disabilities, women 

of lower socioeconomic status, and other underrepresented and understudied populations. A wider

range of variables such as menstrual and endocrine 

status has been included in research designs.

To ensure that effective research programs 

address alcohol and other drug use among women, 

the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and National Institute on Drug 

Abuse (NIDA) have expanded their research and 

training programs during the past 6 years. From 

basic to applied science, studies have been supported

that examine the sexual and gender differences and

similarities among men and women. These studies

focus on gender differences and similarities in biology,

psychology, and response to environmental factors.

Moreover, a major new emphasis has been placed 

on the family as the unit of analysis.

Alcohol Abuse

Women’s use of alcohol has resulted in a major

public health problem. Women represent one-third 

of the estimated 14 million alcohol-abusing or alcoholdependent people in the United States. An estimated 

6 percent of women consume two or more drinks 

daily. Women in the United States continue to use 

alcohol as a drug of choice. The National Longitudinal Alcohol Epidemiological Survey (NLAES), 

conducted in 1992, found that a third of American

women aged 18 and older were current drinkers 

Cochairs

Mary Dufour, M.D., M.P.H.

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

Mary McCaul, Ph.D.

Johns Hopkins University

Cora Lee Wetherington, Ph.D.

National Institute on Drug Abuse

National Institutes of Health 

Sharon Wilsnack, Ph.D.

University of North Dakota 

Rapporteur: Catherine Bolek, M.S.

23

VOLUME 2
24

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

and 21 percent were former drinkers. The Diagnostic

and Statistical Manual, Fourth Edition (DSM-IV),

reports that nearly 4 million women (4.1 percent 

of American women) were alcohol abusers and/or 

alcohol-dependent.

Men continue to outnumber women in terms 

of alcohol consumption — women consume a smaller

quantity and overall have fewer alcohol-related problems and symptoms of dependency than do men. In

the case of women who are heavy drinkers, however,

the number and types of problems associated with, 

and resulting from, alcohol consumption may equal 

or surpass those of men. Alcohol-dependent women

frequently experience greater physiological impairment,

with earlier onset, once they begin to drink heavily.

Such patterns appear later in the drinking careers of

men who use alcohol heavily. Women who are alcoholics develop associated liver disease, alcoholic cardiomyopathy, and brain disorders earlier in their 

drinking careers than do men, and do so despite 

their lower quantity of alcohol consumption. Proportionally, more alcoholic women die from cirrhosis

than do alcoholic men. Once the onset of alcohol 

abuse is established, however, women do enter 

treatment programs sooner than do men. 

Tobacco Use 

Tobacco use is responsible for more than 

500,000 deaths in the United States each year, and

nearly a third of these deaths occur among women. 

It is still the most preventable cause of death in this

country. Although tobacco smoking prevalence has

declined among men by 84 percent over the past 

three decades, smoking rates among women declined

only 21 percent during this same period.

Adolescents are initiating smoking at younger 

ages. Forty percent of white, 33 percent of Hispanic,

and 12 percent of black female high school students

report that they are current smokers. The increase in

smoking rates among adolescents, particularly females,

has been linked to the tobacco industry’s advertising

and promotion campaigns.

Women who smoke experience early menopause,

which may place them at higher risk for coronary

artery disease. Smoking rates among higher income

white and black women decline as a function of

income, whereas Hispanic women have slightly 

higher rates of smoking as income rises. Black 

women are less likely to stop smoking than other

groups of women. Moreover, black women are 

more likely to smoke higher tar and nicotine brands,

which places them at increased risk for coronary 

artery disease, cancer, and cerebrovascular disease. 

Drug Abuse

In 1995, the National Household Survey on 

Drug Abuse reported that an estimated 12.8 million

Americans ages 12 and older used an illicit drug during the past 30 days. Furthermore, 4.3 million women

of childbearing years reported using illicit drugs in 

the past month. Although fewer women than men 

use drugs, the potential consequences of drug abuse

are often different for women. The National Pregnancy

and Health Survey conducted in 1992 found that

221,000 women used illicit drugs while they were

pregnant. The National Comorbidity Survey, conducted between 1990 and 1992, found that 6 percent 

of American women between the ages of 15 and 54

years met the criteria for lifetime drug dependence.

This illicit drug use in women has been associated 

with other comorbid disorders.

Studies have reported that many women who 

have psychiatric disorders may be predisposed to 

drug abuse once physician-directed pharmacologic

therapy is initiated. Psychiatric disorders, particularly

depression, have been identified as a predisposing 

factor in the use of crack cocaine. Familial associations have also played a role. For example, it has been

demonstrated that women who have conflicted relationships and a diminished psychological attachment 

to their mothers may be at risk for drug use. The 

same is true of women who have been the victims 

of crime. Anorexia nervosa, bulimia, and other eating

disorders have been correlated with substance abuse,

and present indications are that the more severe the
“In view of the trends toward an aging American

population, and the relative longevity of women in

comparison to men, special attention should be paid to

the impact of alcoholism and drug abuse on the health

of perimenopausal and postmenopausal women.”

Nancy K. Mello, Ph.D.

Harvard Medical School

25

VOLUME 2

diet or binging behavior, the more likely a woman 

will meet the criteria for substance abuse and/or 

dependency. Additionally, such eating disorders 

appear to increase the chance that the consequences 

of drug and alcohol use will be negative. Profiles

demonstrate that many women who are potential 

drug users have low self esteem, are single mothers

who may have limited parenting skills, are often 

school dropouts with few marketable job skills, 

and have been exposed at least once to a sexually

transmitted disease. Such women may associate 

themselves with men for protection and support, 

but frequently do so with men who are themselves

involved with drug use. Furthermore, a growing 

body of evidence suggests the existence of a gender 

difference in the effects of drug abuse and addiction;

women proceed more rapidly to drug dependence 

than do men once they begin using drugs.

One of the most dangerous and potentially lifethreatening consequences of illicit drug use is the 

risk of HIV infection. AIDS is now identified as the

fourth leading cause of death among women between

the ages of 15 and 44 years. By the middle of 1997,

more than 96,075 cumulative cases of AIDS were

reported among women, and 63 percent of these AIDS

cases could be related to intravenous drug use. AIDS

may be a factor in a woman’s health even if she does

not use intravenous drugs. Heterosexual contact with

an intravenous drug user has been found to be a significant component in the transmission of this virus. 

Most of the women involved are young, use crack

cocaine, and trade sex for drugs or money. Statistics

indicate that 72 percent of AIDS cases in women 

may be attributed to intravenous drug use and 

28 percent of cases to heterosexual contact with 

injection drug users. In men, 22 percent of AIDS 

cases are related to intravenous drug use and only 

1 percent to heterosexual contact with intravenous

drug users. Fifty-four percent of pediatric AIDS 

cases have been related to either the mother’s use 

of intravenous drugs or her sexual contact with 

men who are injection drug users.

Recommendations from the 1991 Working Group 

on Mental Health and Addictive Disorders

The 1991 Hunt Valley Working Group 

recommended attention to the following:

• Comorbidity among mental illness, substance 

use, and physical illness. Identification of certain

subgroups of women at risk (genetically, by psychosocial history, chronic stress) for comorbid 

illness could prove useful for preventive 

treatment efforts.

• Genetic and environmental factors contributing 

to mental and addictive disorders through 

genetic epidemiology, to develop promising 

prevention strategies.

• Significant gender differences in prevalence 

of mood, anxiety, and personality disorders.

• Biological and psychological gender-related 

variables related to the development, onset, 

course, treatment, and relapse of mental and 

addictive disorders, including early developmental history and the role of sexual and 

physical abuse. 

• Gender differences in cognitive and/or 

personality variables that may influence 

onset or recurrence of disorders.
26

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

• Psychological and biological factors linked to 

gender in suicide attempts and completions 

across the life span.

• Gender differences in grief reactions and 

depression following bereavement.

• Gender differences in the development of phobic avoidance for social and specific phobias and agoraphobia.

• More refined behavioral and pharmacologic 

interventions for alcohol and other substance 

use disorders that consider issues unique to

women, including demands of caregiving for 

children and other family members.

Summary Recommendations from Beyond Hunt Valley

(September 26-27, 1996)

• Mental and Addictive Disorders Across the Life 

Span. Encourage research on the interactions

among biological, psychological, and social 

factors related to mental and addictive disorders across the life span of women. 

• Gender Differences in Brain Function. Stimulate

research on gender differences in brain function,

specifically the effect of gonadal hormones on 

the developing brain and their relationship to the

formation of sexually dimorphic brain structures

and processes and how these distinctions could be

related to gender differences observed in persons

affected by mental and addictive disorders.

• Long-term Effects of Violence and Victimization.

Encourage and support research on (a) psychological and biological effects of sexual assault in childhood and (b) intervention research designed to

prevent and/or treat the long-term mental health

effects of experiencing abuse and violence.

• Gender Differences in Etiology and Consequences.

Conduct basic research (both human and animal) as well as epidemiological and longitudinal

research directed at identifying gender differences

in the etiology and consequences of alcohol and

other drug use, abuse, and addiction.

• Antecedents, Pathways, Risk Factors, and Protective

Factors. Conduct research on antecedents, pathways, risk factors, and protective factors involved

in alcohol and other drug abuse by girls and

women, with emphasis on early identification 

and a full spectrum of prevention interventions.

• Co-existence with Mental Disorders. Conduct 

research on the co-existence of alcohol and other

drug dependence with psychiatric disorders, especially depression, posttraumatic stress disorder

(PTSD), anxiety disorders, and eating disorders.

• Alcohol and Other Drug Abuse Treatment Models.

Expand research examining the development 

and effectiveness of alcohol and other drug abuse 

treatment models that are specific to the unique

needs of women. Such models should include

treatment for addiction as well as any co-existing

psychiatric disorder (e.g., depression, anxiety, 

PTSD, eating disorder). These models must also 

be culturally relevant.

• Women and Alcohol. More research is needed to:

– ascertain mechanisms of gender differences 

in alcohol metabolism;

– determine the causes and mechanisms 

of differential susceptibility of women 

to alcohol organ damage; 

– explain and quantify the relationship 

between alcohol consumption, and bone 

density and osteoporosis; 

– examine the long-term consequences of 

consuming alcohol while on estrogen 

replacement therapy;

– determine if the relationship between 

alcohol consumption and breast cancer is

causal and, if so, by what mechanism(s); and

– determine optimal treatment methodologies

for women alcoholics.
27

VOLUME 2

• Address Diversity in All Research Studies. Many 

measurement tools used today were normed on

white male reference groups. These tools need to

be re-examined and validated for use with female

and diverse ethnic groups. Similarly, there is a 

need for female-centered models of treatment. 

In developing these models, researchers need 

to be cognizant of the variables important in

women’s mental health, including racial, religious,

socioeconomic status, and sexual orientation.

• Integrate Cross-disciplinary Research, from Molecular

Level through Societal Level. Mental disorders and

alcohol and other drug abuse are complex problems that involve mutually interactive biological,

behavioral, and societal factors. Research is 

needed that integrates across these levels of analysis to understand this complexity and provide

comprehensive solutions. Given that researchers

typically receive training in only one of these levels, cross-disciplinary collaborations are needed 

to develop more integrated programs of research.

Prime topical areas for such cross-disciplinary collaborations in women’s mental health and addiction include HIV/AIDS, physical and sexual abuse,

posttraumatic stress disorder, and depression.

SCIENTIFIC PROGRESS

SINCE EST ABLISHMENT

OF ORWH

Gender as a Research Variable

Researchers are now paying significant attention 

to gender differences in the analysis and reporting of

epidemiologic data. For example, gender differences 

in body water and body fat were taken into consideration in the analyses of the groundbreaking NLAES.

This national epidemiological survey of nearly 43,000

people was designed to ascertain prevalence estimates 

of alcohol and other drug use disorders.1 Another 

landmark national probability sample survey focused

on alcohol and other drug use among women.2,3

There was also a significant increase in comorbidity

studies and in gender analysis. In addition, studies 

are beginning to examine the role of the menstrual

cycle in patterns of alcohol and other drug use. Consideration of the variations in gonadal hormone levels

across the menstrual cycle will lead to a better understanding of their influences on variations in alcohol

metabolism across the menstrual cycle.4,5

Study Design Issues

Progress in study design includes the following:

• A movement from single toward bivariate and 

multivariate study designs.

• New strategies and research methods, including

oversampling, have resulted in improvements in

the recruitment into clinical studies of minorities,

older women, lesbians, women of lower socioeconomic status, women with disabilities, and other

underrepresented and understudied populations.

• Recognition of the importance of effective dosage,

with minimal side effects, when prescribing 

medications for female subjects (patients).

• Recognition and focus on polydrug/alcohol

use/abuse.

• Issues of access, entry, and retention of women 

in treatment.

Domestic Settings

The family as the unit of analysis is a major 

new focus, in particular the interaction of prenatal

alcohol and drug exposure and postnatal environment and status of the mother and family. Violence 

and sexual abuse are now recognized as factors in 

alcohol and drug use among female victims. This 

has led to recognition that abused women need 

comprehensive services that may go beyond drug 

and alcohol treatment. This is especially true since

there is now a better recognition that improved data 

on women’s drug and alcohol use will result in better

prevention and treatment programs through the inclusion of basic biological, epidemiologic, and etiologic

study findings. 
28

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Genetic Studies

Since 1991, studies have examined the genetic

basis of alcoholism in women.6-10 The results of 

these studies do not lead to definitive conclusions 

concerning the role of inheritance in alcoholism 

among women, but they do permit tentative conclusions that can be applied to future research. Studies

demonstrate that alcoholism can be genetically transmitted from generation to generation regardless of the

gender of the offspring. Studies with twins have indicated that familial similarities may result from both

genetic factors and shared environmental factors. 

In the case of women alcoholics, a lack of consistent 

findings makes interpretation of data from twin studies

difficult. McGue and Slutske believe the inherited 

component of alcoholism in women is less markedly

expressed in women than in men.11 Despite the 

strong evidence for an environmental influence on the

etiology of alcoholism, there has been no systematic

study of environmental factors and their influence 

on alcohol use in terms of gender.11 Heath and colleagues have identified several possible behavioral

pathways that may interact with genetic influences 

on alcoholism.12 Prescott and colleagues report that

personality characteristics and parental psychopathology are important indicators of problem drinking 

and alcohol dependence in women.9

Psychological and Psychiatric Functions

Women, like men, may be divided into two 

populations based on their measured patterns of 

psychological and psychiatric functioning. The first

population is characterized by negative emotionality

and internalized psychiatric disorders such as anxiety

states and depression. The second population exhibits

poor behavioral control and externalizes psychiatric

disorders through substance abuse and antisocial personality disorder.11 Limited data support the hypothesis that the biological markers found in men alcoholics

are also found in women. While there is evidence for

some shared biological markers, some markers could

not be used to differentiate high-risk women from 

low-risk with a degree of statistical significance.13

Reproductive Physiology

Many women of childbearing age (15 to 44 years)

experience reproductive health problems as a result 

of alcohol and drug use. Even social drinkers may

experience disruption of the menstrual cycle. Heavy 

or long-term use may result in abnormalities in the

neuroendocrine system that may then impair fertility.14

Moreover, studies have shown that spontaneous abortion is a frequent concomitant of alcohol and cocaine

abuse. In addition to reproductive consequences, 

biochemical gender differences between alcohol 

and drug effects and female hormones may contribute to an increase in liver toxicity.15

Biochemistry and Physiology

Women have less total body water volume than 

do men of comparable weight and height. Ingested

alcohol diffuses uniformly into all body water regardless of whether it is intra- or extracellular. Women can

achieve higher blood alcohol concentrations (BACs)

than can men who consume identical amounts of 

alcohol. Research indicates that less gastric alcohol 

dehydrogenase (ADH) activity in women may further

contribute to a gender difference in BAC as well as 

the heightened physiological responses to alcohol. 

Initial metabolism of alcohol in the stomach by ADH

decreases the availability of alcohol to the body. The

lesser gastric ADH activity in women relative to men

allows more alcohol to diffuse throughout their bodies.

Fluctuations in hormone levels during the menstrual cycle may further affect the rate of alcohol metabolism. This would make women more susceptible to

elevated BACs at different times in the menstrual cycle.

Osteoporosis

Alcoholics are known to be at increased risk 

for osteoporosis. In postmenopausal women, paradoxically, low levels of alcohol consumption appear 

to increase bone density. 

Another study indicates possible deleterious 

effects on other health outcomes when even small

amounts of alcohol are consumed during estrogen
29

VOLUME 2

replacement therapy. When postmenopausal women

taking oral estrogen consumed half a drink, the levels

of blood estrogen nearly doubled; after three drinks,

levels nearly tripled. Other large epidemiologic studies

have demonstrated that alcohol consumption at levels

as low as one to three drinks per week is associated with

an increased risk of breast cancer. The demonstrated

elevation of blood estrogen levels associated with alcohol consumption has led to the suggestion that alcohol

intake during estrogen replacement therapy may contribute to a possible mechanism for breast cancer.

Violence and Victimization

Epidemiological studies have shown that victimization (e.g., physical and sexual assault and natural

disasters) of women and children is associated with

alcohol and drug abuse. Longitudinal data from a representative national sample of women have shown that

crime victims were 9.7 times more likely to have major

alcohol-related problems and 17 times more likely to

have major drug abuse related problems than nonvictims. Women who had reported being raped were 

13 times more likely to have multiple alcohol-related

problems and 26 times more likely to experience multiple drug-related problems. The implications from 

this and other related studies are that women who 

have been victimized may need special ancillary 

treatment such as long-term counseling related to 

victimization to increase the probability of a successful alcohol and other drug treatment outcome.16

Childhood sexual abuse has been associated with

drug abuse in women in several studies.17,18 For example, a study of women in drug abuse treatment found

that 70 percent of the women reported histories of

physical and sexual abuse, with victimization beginning before 11 years of age and continuing on a serial

basis.18 The path by which substance abuse develops

following childhood sexual abuse experiences in women

is unclear, and further research is needed to understand the etiology of this strong correlational finding.

Women who abuse drugs may be more vulnerable to victimization than men. A recent study of 

homicide in New York City found that 59 percent 

of white women and 72 percent of black women 

had been using cocaine prior to their death compared

with 38 percent of white males and 44 percent of 

black males. Although cocaine is used by more men

than women, its use is a far greater risk factor for 

victimization for women than for men.19

Nicotine

In a study of nicotine withdrawal in female 

twins, three subclasses were identified that represent 

a continuum from mild to severe nicotine withdrawal.

Women from the severe withdrawal class were characterized by reported hand tremors and depression.

Reported lifetime alcohol dependence rates were a

function of severity class of nicotine use. Among 

smokers from the most severe nicotine use class, 

elevated rates of major depression, conduct disorder,

and anxiety disorder were also reported. These findings may have a significant effect on the development

of more efficacious treatment interventions.20

Behavior

To study pathways to alcohol and drug use and

risky sexual behavior, researchers used behavioral, 

psychiatric interview, and self-report measures to 

index behavioral dysregulation, negative affectivity,

childhood victimization, antisocial behavior, and 

affiliation with adult males. The research showed 

that behavioral dysregulation, negative affectivity, 

and childhood victimization were positively correlated

with alcohol and drug use and risky sexual behavior.

Age of menarche was correlated with association 

with risky sexual behavior. Implications for prevention and treatment include the potential use of 

behavior modification techniques typically used 

with conduct-disordered adolescents.21

Interrelationships among alcohol use, aggressive

behavior, and episodes of acute alcohol-related aggression have been examined. Prior aggressive behavior

and alcohol use predicted later episodes of acute 

alcohol-related aggression. Early aggressive behavior

predicted later alcohol use. Research results have

shown that the interaction of gender and alcohol 
30

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

was significant, such that prior alcohol use was a better

predictor of alcohol-related aggression in females, and

prior aggression was a better predictor for males. These 

data suggest that gender is the best predictor of the

direction of the relationship between alcohol use,

aggression, and alcohol-related aggression over time.22

Treatment

In a study of residential treatment outcomes in

cocaine-abusing women, the presence of their children

during treatment enhanced retention in care. Other

benefits may be improvements in the mother-child

relationship and postdischarge treatment outcomes.23

In a study of postpartum women in outpatient drug

abuse treatment, retaining custody of the infant was 

a strong predictor of retention in intensive day services, particularly for voluntary clients.24

A recent national study of individuals in drug

abuse treatment programs between 1991 and 1993 

(the drug abuse treatment outcome study or DATOS)

showed that women who had at least 28 days of treatment (with at least 14 days in short-term inpatient

care) had sharp reductions in their use of illicit drugs,

HIV risk behavior, and illegal activities. For instance, 

at intake 84 percent of the women who were admitted

to long-term residential treatment programs admitted

using illegal drugs every day or at least once a week.

Twelve months after treatment, only 28 percent continued to abuse drugs. Short-term inpatient treatment

women also showed significant reductions in illegal

drug use a year after their treatment with 86 percent

admitting use at intake and 32 percent reporting use

after one year.

Women who abuse drugs face a variety of barriers

including barriers to treatment entry, to engagement 

in treatment, and to long-term recovery. Barriers to

entry include a lack of economic resources, referral 

networks, women-oriented services, and conflicting

child-related responsibilities. Because women have

many specific needs, a number of components of 

treatment have been found important in attracting 

and retaining women in treatment. These include 

the availability of female-sensitive services, nonpunitive

and noncoercive treatment that incorporates supportive

behavioral change approaches, and treatment for a

wide range of medical problems, mental disorders, and

psychosocial problems. One research study showed

that treatment of drug-dependent women was more

likely to be successful if it was provided in a mutually

supportive therapeutic environment and if it addressed

the following issues: psychopathology (e.g., depression), a woman’s role as mother, interpersonal relationships, and the need for parenting education.

Animal Studies

Animal studies have shown that fundamental 

gender differences may exist in the reinforcing and

stimulus properties of abused drugs. On several 

measures of stimulant-induced activity, females 

exhibit more responsiveness than males; moreover, 

this responsiveness varies with the estrus cycle. 

Gender differences have also been reported in selfadministration of cocaine. When cocaine infusions

were made contingent upon increasing numbers of 

bar presses, female rats made substantially more 

presses than males, and their level of cocaine selfadministration varied as a function of the estrus cycle.

Etiology – Drug Abuse

The progression or developmental stages of drug

involvement appear to differ according to gender. In

the progression from legal drug use to illicit drug use,

for example, cigarettes seem to play a major role for

women; for men alcohol alone is sufficient.25 With

regard to initiation into illicit drugs, data suggest that

women are more likely to begin or maintain cocaine

use in order to develop more intimate relationships,

while men are more likely to use the drug with male

friends and in relation to the drug trade.26

Comorbidity – Opiates and Cocaine

Studies of comorbid psychiatric disorders in 

opiate and cocaine abusers have reported findings 

consistent with the epidemiology of these disorders 

in the general population, specifically, a higher percentage of affective and anxiety disorders in women than
31

VOLUME 2

in men. The rate of co-occurring substance abuse 

disorder and PTSD is relatively high for women. 

Data from a study on female crime victims, for 

example, indicate that those suffering from PTSD were

17 times more likely to have major drug abuse problems than nonvictims. Furthermore, it has been shown

that individuals with a trauma history and PTSD symptoms utilize substance abuse inpatient services more

frequently than do their non-PTSD counterparts. This

has led researchers to speculate that the co-occurrence 

of substance abuse and PTSD often predicts a more

severe course than would ordinarily be present with

either disorder alone. 

GAPS IN KNOWLEDGE

Among the gaps in women’s health research on

alcohol, tobacco, and other drug use are:

• Alcohol and other drug use and associated 

disorders in female populations by race, ethnicity,

socioeconomic status, sexual orientation, age

group, and other variables.

• Studies of genetic, physiologic, psychiatric, psychosocial, and behavioral antecedents of alcohol

and other drug use including risk and protective

factors, particularly replication studies.

• Prevention research expanded to include interventions based on female-specific antecedents,

pathways, and risk and protective factors.

• Well-designed theoretically based treatment 

models that address female-specific issues.

• Gender differences in the etiology and consequences of alcohol and drug use, abuse, 

and dependence.

• Hormonal factors in alcohol and drug use, abuse,

and dependence.

• Mediators of a genetic influence on alcohol and

other drug use, abuse, and dependence.

• Identification of barriers to treatment seeking 

and entry.

• Life span issues.

• Increase in career opportunities including 

multidisciplinary training.

• Gender-specific behavioral, biological and 

medical effects of alcohol and drug abuse.

• Gender-specific biological and behavioral mechanisms that underlie alcohol and drug abuse.

• The role of dieting and eating disorders in 

alcohol and drug etiology.

• Factors that may result in over prescription 

and abuse of psychotherapeutic agents.

RESEARCH 

RECOMMENDATIONS

The following recommendations are not listed 

in priority order.

Reproductive Physiology

Examine basic biological processes across the 

menstrual cycle. This research should include animal

studies on all phases of menstruation and should be

developed with regard to cross-species generalities 

and new animal models. Such research should result 

in development of better pharmacokinetics data related

to specific phases of the menstrual cycle and a description of the role of hormones in the metabolism of 

alcohol and drugs.

Drug Use Patterns and Treatment Models

Describe the role of gender in sensitivity to 

pain medication, the biochemical effects of drug use,

self-medication, and use of psychotropic prescription

drugs, including health benefits, in the development 

of treatment strategies for alcohol and drug use. These

should include gender-based studies of drug interactions (e.g., steroids and brain/opiate receptors).
32

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Developmental Effects

Examine effects of maternal alcohol and drug 

use on children’s use of alcohol and drugs. Included

should be a study of developmental neurochemistry 

as affected by pharmacologic agents and alcohol.

Predisposition to Mood, Eating, and Anxiety Disorders

Further examine the role of mood, eating, and 

anxiety disorders in alcohol and drug use, as well 

as those psychological, social, and biological factors

that predispose young women to these disorders.

Effects of Victimization and Violence

Study sexual abuse during childhood, and the

interaction of other sexual or violent victimization 

of women and their use of alcohol and drugs. These

studies should seek to clarify the correlations between

the occurrence of alcohol and drug use with these

experiences and explore psychosocial and biological

mechanisms.

Biological and Physiological Gender Differences

Detail gender differences in health consequences

that occur across a spectrum of consumption and use

levels. Research should be designed to reveal gender 

differences in the sensitivity of specific organ and 

biological responses to alcohol and drug use that 

will lead to a better understanding of mechanisms 

(e.g., first-pass metabolism). This should include 

additional basic animal and human studies to 

investigate gender-based biological and physiological differences.

Descriptive Studies in Special Populations

Examine special populations as defined by race,

ethnicity, socioeconomic status, sexual orientation, 

age group, and so on. Furthermore, there is a need 

for additional studies of alcohol and drug using 

women who successfully recover.

Multidisciplinary Research

Develop collaborative research programs between

NIAAA and NIDA. Furthermore, multidisciplinary

research should be fostered that examines biological

effects, gender differences, psychosocial, behavioral,

cognitive, psychiatric, general health, family, and legal

consequences as well as specific sexually transmitted

diseases and reproductive effects and their relation to

alcohol and drug use. Emphasis should be placed on

factors that affect the conduct of multidisciplinary

research, particularly the development of strategies 

that overcome barriers to such research.

Gender-sensitive Surveys

Construct a survey tool that is designed to 

capture developmental data specific to women. 

NIH should further the development and standardization of existing and experimental gender-sensitive

assessment tools. Better measurement and survey 

methods should be encouraged so as to more carefully characterize drug and alcohol use and other

women’s health factors. 

Prevention Strategies

Develop counseling techniques for adolescent 

and adult females who may have a genetic risk of 

alcohol and drug use and/or abuse. Prevention 

strategies should also be developed to account for 

the role of childhood violence and sexual abuse 

in adolescent and adult females’ use of alcohol and

drugs and studies should be related to appropriate

intervention. Additionally, prevention designed to

reduce individual and social environmental risk 

factors should be undertaken with an emphasis 

on early intervention with girls and adolescents. 

Interventions should be based on etiology and 

pathway findings for females versus males. Implementation strategies should be developed with wellcontrolled evaluations for alcohol and drug use in 

pregnant women and women of childbearing age.
33

VOLUME 2

Media and Advertising

Examine further the influence of the media and

advertising on a woman’s use of alcohol and drugs

including tobacco. 

Gender-based Treatment

Examine the role of ethnic and gender variation 

in how alcohol and drug users perceive the need for

treatment. These studies should examine the motivators and barriers that may affect treatment-seeking

behavior as well as the role of co-occurring problems such as history of physical and sexual abuse, 

and serious affective and anxiety disorders on 

treatment outcome and the development of 

appropriate therapies.

Longitudinal studies from childhood through

adulthood should be aimed at investigating gender 

differences in the nature and extent of drug-using

behaviors; gender differences in the pathways and

determinants of initiation, progression, and maintenance of drug use; and gender differences in the basic

behavioral mechanisms underlying drug dependence,

vulnerability, and protective factors. 

Clinical Trials of Treatment Protocols

Undertake well-controlled clinical trials with 

gender-sensitive models (single vs. mixed gender;

mixed gender; gender sensitivity absence or presence).

Gender similarities and differences in the recovery

process should be explored in these studies. Additionally, gender differences and pharmacotherapeutic effectiveness and other effects on women’s health 

(e.g., fertility) should be noted. Other factors to be

investigated include treatment-sensitive life span 

stages, clarification of “gender sensitivity,” and exploration of what is required in the therapeutic process 

to increase efficacy.

Inclusion of Gender as a Research Variable

Develop an integrated strategy to include women

in all phases of addiction research, including both 

biological and biomedical studies. This effort should

include the introduction of females in animal models

research through such mechanisms as modification 

of existing NIH guidelines for animal studies.

Training and Career Development

Encourage career opportunities for women in 

alcohol and drug research through the development 

of new program announcements.

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Mendelson JH. Sex differences in plasma cocaine levels and

subjective effects after acute cocaine administration in human

volunteers. Psychopharmacology 1996;124(4):346-54.

McGue M, Pickens RW, Svikis D. Sex and age effects on 

the inheritance of alcohol problems: a twin study. J Abnorm 

Psychol 1992;101:3-17.

Mitchell JE, Pyle R, Echert ED, Hatsukami D. The influence 

of prior alcohol and drug abuse problems on bulimia nervosa

treatment outcome. Addict Behav 1990;15:169-73. 

Ninth Special Report to the U.S. Congress on Alcohol and

Health from the Secretary of Health and Human Services. 

June 1997. Bethesda, MD: U.S. DHHS, NIH Publication 

No. 97-4017.

Vogeltanz ND, Wilsnack SC. Alcohol problems in women: 

risk factors, consequences and treatment strategies. In: Gallant

SJ, Keita GP, Royak-Schaler R, editors. Health care for women:

psychological, social and behavioral factors. Washington, D.C.:

American Psychological Association, 1997.
BEHAVIORAL AND 

SOCIAL SCIENCES

BACKGROUND

Definitions

The World Health Organization defines health

as “a state of complete physical, mental, and

social well being and not merely the absence

of disease or infirmity.”1 This definition not only

expresses the interrelatedness of mind, body, and 

social context — well represented by George Engel’s

biopsychosocial model2 — but also stresses the 

positive meanings of health. The Working Group 

on Behavioral and Social Sciences approached its 

topic in the same encompassing way.

A similar approach informs the definitions 

developed by the NIH Office of Behavioral and 

Social Science Research (OBSSR), which has identified these cross-cutting themes in behavioral and 

social sciences research: 

• An emphasis on theory-driven research.

• The search for general principles of behavioral 

and social functioning.

• A developmental, life span perspective.

• An emphasis on individual variation across

sociodemographic categories such as gender, 

age, and sociocultural status.

• A focus on both the social and biological 

context of behavior.

The OBSSR report3 states that “for the purposes 

of this definition, the term ‘behavioral’ refers to overt

actions; to underlying psychological processes such as

cognition, emotion, temperament, and motivation; and

to biobehavioral interactions. The term ‘social’ encompasses sociocultural, socioeconomic, and sociodemographic status; biosocial interactions; and the various

levels of social context from small groups to [the societal influences of] complex cultural systems . . . .”

These definitions suggest that looking at the

behavioral and social dimensions of women’s health

means looking not only at women’s actions, cognitions,

and emotions but also at contextual factors including

socioeconomic status, race, ethnicity, age, functional

status (degree and type of disability), employment, 

geography, social roles, power relationships, and 

sexual preference — as well as at the interaction 

of each of these with biological factors. To take one 

example, a woman’s adherence to medical advice to

reduce the risk of osteoporosis by taking calcium is 

a behavioral issue with physical consequences, and 

it cannot be understood without considering her 

financial ability to pay for the calcium supplements 

and other social factors. 

Behavioral and Social Dimension in Previous 

ORWH-sponsored Meetings

Although the Bethesda gathering was the first

ORWH-sponsored meeting to convene a working

group on behavioral and social sciences research, 

Cochairs

Virginia S. Cain, Ph.D.

Office of Behavioral and Social Sciences Research

National Institutes of Health

Karen Scott Collins, M.D., M.P.H.

The Commonwealth Fund

Rapporteur: Susan Baird Kanaan 

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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

it was not the first to consider the behavioral and 

social dimensions of women’s health. At the 1991 

Hunt Valley meeting, they were an explicit part of 

the discussions of each phase of the life span and of 

the analyses and recommendations of the cross-cutting science groups. For example, the 1991 report 

discusses the ways in which economic and cultural 

conditions limit women’s health choices, the realities 

of violence and abuse for many women, the disproportionate disease burden borne by women of color,

the role of social and behavioral risk factors in the

development of disease, and the significance of 

social supports for mental and physical health.

In the 1996 Philadelphia meeting, the topic of

behavior was paired with neuroscience and brain 

study in the working groups, thus focusing on the 

biological determinants of behavior. Broader behavioral and social themes continued in the meeting as 

a whole. Two working groups are of particular note.

First, the Working Group on Research Design: Multidisciplinary Perspectives recommended, among 

other things, the structuring of NIH funding and

review processes to encourage multidisciplinary

research and new research designs; the convening 

of multidisciplinary conferences; rewards for multidisciplinary research within academic institutions; 

and multidisciplinary training and mentoring for

researchers. Second, the Working Group on Racial,

Ethnic, and Cultural Diversity in Clinical Research

offered a host of recommendations for ways in 

which NIH can “involve and benefit diverse communities of women in research projects.”4

The report of the 1997 New Orleans meeting 

is filled with observations and recommendations 

about behavioral and social dimensions of health 

in each stage of the life span — perhaps most 

notably in the section on adolescence. For example, 

the Working Group on Adolescence called attention 

to the health outcomes of adolescent risk behavior,

including increasing violence and smoking among 

girls, and the effects of body image and self concept 

on health behaviors and outcomes. ORWH Director

Vivian Pinn, M.D., also sounded several behavioral 

and social themes in her introductory remarks. She

said the forthcoming Santa Fe meeting would focus 

on “factors that contribute to differences in health 

status and health outcome among different populations of women, including biologic, genetic, race, 

culture and ethnicity, psychosocial and behavioral 

factors, educational influences, traditional and 

alternative practices, environment, poverty and 

socioeconomic status, access to health care, and 

[occupation].”5

The Santa Fe meeting picked up the challenge, 

as can be seen in a few examples. The Working 

Group on the Prenatal Years noted the need for 

information about what issues study populations, 

not just researchers, believe are important. The 

Working Group on Infancy/Childhood recommended

the use of racial and socioeconomic demographic 

indicators in all research, and urged cultural sensitivity and flexibility. The Working Group on Adolescence stated that “the major causes of morbidity 

among female adolescents are largely . . . related to

their behaviors,” and it highlighted seven social and

behavioral risk factors in need of investigation. The

report of the Working Group on Reproductive and

Middle Years includes extensive recommendations 

on women of color and on poverty and urban 

health. A section on women with disabilities in 

this age group recommends research on body 

image, fitness, and violence, among other things. 

And the list could continue.

Major Themes in the Bethesda Working 

Group Discussion

The Behavioral and Social Sciences Working 

Group that met in Bethesda in November 1997 had 

the task of pulling together this immense set of issues

and identifying the activities that would most advance

this critical and cross-cutting area of knowledge about

women’s health. Participants agreed that behavioral 

and social science research on women’s health could

best be facilitated by basic and methodological 
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research and some key policy changes. The discussion generated a set of process and policy objectives

that members felt would create more favorable conditions for behavioral and social science research on

women’s health. Most, but not all, of these objectives

related to NIH policy and programs, with the chief 

aim of reinforcing and extending the progress already

made by ORWH and OBSSR. The overall goals are

greater consistency among the institutes and more

overlap between women’s health and behavioral 

and social science research.

The working group members stressed the importance of learning from and joining in partnerships 

with others with shared priorities, particularly those

who have previously dealt with similar issues. Several

examples were cited, notably the AIDS community,

which has stimulated new research paradigms and

modeled collaboration among researchers, providers,

consumers, and the support community. Another 

is the Centers for Disease Control and Prevention,

which has shown a strong commitment to behavioral

and social science research. In another vein, the Pan

American Health Organization and the World Bank

have developed training programs and materials for

institutional leaders on gender analysis and used 

them in many countries.6 Of direct relevance are 

two conferences convened in 1994 and 1996 by 

the American Psychological Association (APA), with

ORWH as a cosponsor, on the research agenda for 

psychosocial and behavioral factors in women’s 

health. APA has published the recommendations 

from the first meeting.7

Working group members expressed urgent concern about the impact of current welfare-to-work 

policies on the health of low-income women. The

rapidly changing policies require immediate attention

to the effect on women and their health. Members 

suggested the possibility of using existing study 

populations of welfare recipients to look at the health

impacts of the withdrawal of financial support. Finally,

violence was another concern that received considerable attention during the discussion.

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

As has been noted, this was the first ORWH 

meeting to convene a working group expressly and

exclusively devoted to behavioral and social science

research. Therefore, progress since 1991 cannot be

assessed in terms of a specific set of recommendations.

Nevertheless, there is a good deal of progress to be

acknowledged — much of it due to the efforts of 

two relatively new NIH offices, the Office of Research

on Women’s Health and the Office of Behavioral and

Social Sciences Research. These program offices within

the Office of the Director at NIH have identified and

highlighted areas that, with increased attention, would

advance the knowledge about women’s health. They

have also taken steps to increase the research activities

in those areas. On a very basic level, as has been documented above, the ORWH-sponsored workshops on

women’s health research have made important strides

in articulating behavioral and social issues and weaving them into the agendas of every sector of women’s

health research.

Research Design

Increased awareness and knowledge of gender and

behavioral and social factors have led to changes in 

the way research is conducted. In this decade, policymakers and health researchers, along with the general

public, have become more aware of the significance 

for health and disease of both gender and behavioral

and social factors. As a result of this awareness and of

explicit law and regulations, survey samples and study

populations more routinely include women and are

more likely to reflect at least some of the geographic,

racial, and ethnic diversity of the general population.

The way research is conducted and reviewed 

also reflects this awareness. A large body of methodological research has illuminated the influence of context on the study or interview situation and the need 

to match interviewers and respondents on certain 

characteristics (e.g., language) to elicit the most valid
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

and reliable data. In addition, behavioral scientists and

women’s health experts more routinely sit on review

panels and study sections. Some review panels even

include consumers.8

Behavioral Methodologies

Behavioral methodologies are becoming a standard

part of health-related research. Health researchers on

health topics are increasingly using the methods developed by behavioral and social scientists. A common

tool is focus groups, which use professionally facilitated

discussion among carefully chosen samples to gather

information on attitudes and behaviors. More broadly,

there is a growing recognition among policymakers 

and researchers of the need to involve community

members in defining key research questions and collecting data on those communities, and of the merits 

of other community-based and participatory forms 

of research. These approaches are helping to challenge and change basic notions about what constitutes “good research,” inevitably pointing the way 

to multidisciplinary research.

Increased Knowledge

More research leads to more knowledge about 

specific behavioral and social factors. Over this decade,

there have been significant advances not only in attitudes toward gender and behavioral and social factors,

but in scientific knowledge about them. Attention to

these factors in health-related research has moved forward in many fields since 1991 through the efforts of

Federal and State Governments, academic institutions, 

and private foundations. A few examples follow:

• Violence has recently been recognized as an 

important issue in the study of women’s health.

Great progress has been made in a relatively 

short time in understanding the extent to which

women experience violence in their lives,9 the 

consequences for women,10 and the development

of effective treatments.11,12 Both The Commonwealth Fund and the National Academy of Sciences, Institute of Medicine, studied violence 

against women and its health implications and

released reports on the subject in 1996.13,14

• Heart disease has long been the major cause of

death among women in the United States, but 

it was not recognized as a major health problem 

in women until recently. The pattern differs from 

men in that cardiovascular disease occurs at older

ages among women, and this may have contributed to the relative lack of research in women.

Since 1991, a number of studies have been and 

are being conducted to fill in gaps in knowledge

about the disease in women (e.g., the Nurses 

Study, PEPI, the Women’s Health Initiative,

SWAN). These studies are carefully examining

behavioral factors, such as exercise, diet, stress, 

and social support and their relationships to 

cardiovascular health outcomes. 

• The rapidly advancing world of genetic research 

is leading to the availability of genetic screening 

for an increasing number of diseases. The discovery of BRCA1 was an important step forward for

women in helping to prevent a disease that may

affect as many as one in nine women during their

lifetimes. However, there are many misconceptions 

about what it means to have or not have BRCA1.

Important research has been conducted examining

women’s perceived risk of breast cancer, evaluating

counseling programs, and identifying women who

may benefit most from counseling.15 The work

going on in the area of breast cancer risk and

counseling is the leading edge of a field that 

will gain in importance as the genetic bases 

of more diseases are discovered.

GAPS IN KNOWLEDGE

During its deliberations, the working group 

concentrated on institutions and practices that are

responsible for developing knowledge. Thus, many 

of the observations below address underlying systems contributing to gaps in knowledge.
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Basic Knowledge

Basic behavioral and social knowledge are 

needed to build “a science of women’s health” that

encompasses biological, behavioral, social, and environmental factors. Basic research questions include:

• How do women make decisions about health 

— including the adoption and maintenance 

of healthy behaviors?

• How do gender roles affect health decisions 

and behaviors?

• What are the effects of culture, including race 

and ethnicity, on health decisions and behaviors?

• What are the effects of social factors — 

socioeconomic status, housing, employment, 

education, and so on? 

• How can current knowledge be used to encourage

health-promoting changes?

Methodology

Strong methodology is the foundation of all 

good research. Strengthening behavioral and social 

science methodology in women’s health research 

would substantially advance the state of knowledge

about women’s health.

• Behavioral and social terms are used and operationalized in varied ways by researchers, partly 

due to the lack of widespread agreement about

standard definitions and measurements. Research

could benefit by having clear and commonly

agreed upon definitions and explicit details about

how terms are to be operationalized and how, if 

at all, definitions and measurements differ from

those used by others. Examples of terms that 

need to be operationalized more consistently: 

adolescent, power differential, role, violence.

• Measures often fail to reflect the realities of

women’s lives — for example, the types of 

physical activities that women routinely 

engage in and women’s employment status.

• Data-gathering techniques and strategies often 

do not involve the people and communities 

on whom the data are being gathered.

• Although women are included in studies 

and surveys, the study populations and 

samples often do not reflect the range of 

racial, ethnic, and economic groups and 

the diversity of women’s roles. Segments 

of the life span are underrepresented, for 

example, pregnant women, elderly women, 

adolescents. Moreover, the retention rate for

women is poor in many studies.

• Gender sometimes is considered only in 

objective or quantitative terms, and studies 

fail to apply a gender analysis that recognizes 

the implications of gender for social roles, 

power, and other factors — and, in turn, 

their influence on health.

Balanced, Consistent Multidisciplinary Efforts 

The working group perceived a varied level 

of commitment among the NIH institutes to the 

inclusion of behavioral and social sciences components in their research. Improvements could be 

made at each of these stages of the process:

• Attention to behavioral and social factors 

(e.g., recruitment of a diverse population, 

retention issues) in research design.

• Inclusion of behavioral and social questions 

in RFAs.

• Higher budgets for multidisciplinary research in

recognition of its potential cost effectiveness.

• Inclusion on research teams of behavioral 

and social scientists who also have women’s 

health expertise.

• Inclusion in review panels and study sections 

of behavioral and social scientists who also 

have women’s health expertise.
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Health Professional Education and Training

Behavioral and social information and 

theory are not consistently or adequately incorporated into health professional education. There 

is no mechanism for updating the information 

that is included. Generally, students and trainees 

are not tested on their knowledge in this area, 

making students unaccountable for what they 

learn and educators unaccountable for what 

they teach.

Knowledge Gaps of Special Concern

• Behavioral interventions: What works, with 

whom, and why?

• Physical activity: Little is known about the 

maintenance of positive behaviors.

• Violence: Knowledge is spotty, with many 

gaps across the life span.

RESEARCH 

RECOMMENDATIONS

Basic Behavioral and Social Science

• Study decisionmaking processes — 

adoption and maintenance of health 

behaviors.

• Investigate gender roles.

• Study culture.

• Study social context.

Collaborative, Multidisciplinary Research that 

Incorporates Behavioral and Social Science into 

Biomedical and Clinical Studies

• Explore preventive factors.

• Study treatment.

• Investigate the care and caregiving experience.

Methodological Research

• Determine innovative measures that reflect 

women’s lives.

• Devise innovative data gathering strategies 

including qualitative and community-based

approaches.

• Explore effective methods of recruiting and 

retaining women in studies.

Funding and Training/Institutional Policy

• Sponsor a workshop on multiple factors affecting

women’s health decisionmaking.

• Develop mechanisms to ensure funding of research

on relevant behavioral and social components.

• Ensure that study sections have adequate 

expertise to review behavioral and social science 

components of women’s health proposals.

• Fund training grants for behavioral and 

social scientists working in medical areas.

• Provide boilerplate language for appropriate 

RFAs in every institute.

The institutions that educate and train health 

professionals should:

• Integrate behavioral and social science relevant 

to women into health professional curriculum.

• Develop a process for integrating new advances.

• Devise ways to test students on their knowledge 

in this area.

Special Initiatives

• Conduct clinical trials related to behavioral 

interventions.

• Explore physical activity.

• Study violence.
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Behavioral and Social Themes in the 

Recommendations of Other Bethesda 

Working Groups

Eleven other working groups referred to 

behavioral and/or social factors in their recommendations, as listed below. 

• Alcohol, Tobacco, and Other Drug Use, Disorders, 

and Consequences: Effects of abuse; parenting 

as an environmental factor; gender-sensitive 

psychosocial treatment.

• Bone and Musculoskeletal Disorders: Quality 

of life issues.

• Cancer: See sections on outcomes and overarching issues.

• Cardiovascular Diseases: References to obesity,

behavioral determinants.

• Digestive Diseases: Target behavioral therapies; 

fund multidisciplinary research on biopsychosocial factors.

• Immunity and Autoimmune Diseases: Environmental 

influences include diet, stress, lifestyle.

• Mental Disorders: Lifestyle and well being included

in outcomes; prevention studies include caregiver

roles; cross-cultural studies recommended.

• Neuroscience: Stress noted as a factor in interactions among systems; social environment 

noted as a dimension.

• Oral Health: See section on women and the 

health care system; also mentions of violence 

and abuse.

• Pharmacologic Issues: Drug compliance and 

drug access.

• Reproductive Issues: See section on general 

considerations.

References

1 The First Ten Years of the World Health Organization,

Geneva, WHO, 1958.

2 Engel G. The clinical application of the biopsychosocial

model. Am J Psychiatry 1980 May:535-43.

3 A Definition of Behavioral and Social Sciences Research 

for the National Institutes of Health. Bethesda, MD: 

Office of Behavioral and Social Science Research.

4 Interim proceedings of the public hearing and scientific

workshop. Philadelphia, PA: Office of Research on

Women’s Health, 1997. p. 104.

5 Interim proceedings of the public hearings and scientific

workshop. New Orleans, LA: Office of Research on

Women’s Health, 1997. p. 26.

6 See, for example, Facilitator’s Guide, Workshop on 

Gender, Health and Development, PAHO, 1997.

7 Research agenda for psychosocial and behavioral 

factors in women’s health, Washington, D.C.: 

American Psychological Association, 1996.

8 As the result of advocacy by the National Breast 

Cancer Coalition, Congress mandated that breast 

cancer survivors be included on the review panels 

of breast cancer research funding being overseen 

by the U.S. Army Medical Research and Materiel 

Command. Consumers have participated on the 

panels since 1992.

9 Resnick H, Kilpatrick DG, Dansky B, et al. Prevalence 

of civilian trauma and posttraumatic stress disorder 

in a representative national sample of women. 

J Consult Clin Psychol 1993;61:984-91.

10 Kessler R, Sommega A, Bromet E, et al. Posttraumatic

stress disorder in the National Comorbidity Survey. 

Arch Gen Psychiatry 1995;52:1048-60.

11 Foa EB, Olasov Rothbaum B, Riggs DS, Murdock TB.

Treatment of posttraumatic stress disorder in rape 

victims: a comparison between cognitive-behavioral 

procedures and counseling. J Consult Clin Psychol

1991;59(5):715-23.

12 Resick PA, Schnicke M. Cognitive processing therapy 

for sexual assault victims. J Consult Clin Psychol

1992;60(5):748-56.

13 Plichta S. Violence and abuse: implications for women’s

health. In: Falik MM, Collins KS, eds. Women’s Health:

The Commonwealth Fund Survey. Baltimore: Johns Hopkins University Press, 1996. p. 237-70.
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

14 Institute of Medicine Panel on Research on Violence

Against Women. Understanding violence against 

women. Washington, D.C.: National Academy 

Press, 1996.

15 Lerman C, Lustbader E, Rimer B, et al. Effects 

of individualized breast cancer risk counseling: 

a randomized trial. J Natl Cancer Inst 1995;

87(4):286-92.
BONE AND 

MUSCULOSKELETAL 

DISORDERS

BACKGROUND

Bone and musculoskeletal disorders are responsible for high disability and high cost to society and thus are of significant public health

importance. Arthritis and orthopaedic conditions,

including fractures due to osteoporosis, are among 

the leading causes of disability and activity limitation 

in the United States (see Figure 1). Many of these conditions are more prevalent in women than men and 

have gender-specific manifestations, etiology, impact,

and possible outcomes of treatment. The initial focus

and efforts in women’s health have been appropriately

on the diseases with acute mortality or female specificity, for example, heart disease and breast cancer.

Now it is timely to focus on the diseases and conditions that reduce the quality of women’s lives and 

limit their activities as well as contribute to large 

health care expenditures.

The Bone and Musculoskeletal Disorders Working Group addressed the disorders in three general 

categories: arthritis and musculoskeletal disability,

osteoporosis and fractures, and orthopaedics and 

physical activity.

The term arthritis refers to more than 100 different illnesses and conditions. The forms of arthritis

more prevalent in women include the most common,

osteoarthritis, which affects about 16 million Americans. Rheumatoid arthritis, affecting 2.1 million, is 

3 times more common in women, and systemic 

lupus erythematosus affects 9 to 10 times more 

women than men.1 Arthritis is currently the most

prevalent chronic condition reported by American

women.2 As shown in Figure 1, it is also a leading

cause of limited activity in the United States and 

represents the third leading cause of bed disability. 

In the National Health Interview Survey, arthritis 

is more commonly reported by women than men 

and is more likely to result in limitations of activity

(Figure 2). Nevertheless, recent studies indicate that

exercise can play a very positive role in arthritis care

and management.3 The toll of arthritis includes 

not only the costs of medical care but also the consequences of arthritis pain — inability to work, 

difficulty in performing activities of daily living, 

difficulty in exercising, and the resulting adverse 

psychological effects.4 Moreover, projections indicate that the number of people affected will continue to grow as the population ages. Self-reported

arthritis in women involved 22.8 million women 

in 1990, and projections indicate that this number 

will grow to 36 million by 2020.5

Women are less likely to undergo restorative 

procedures than men. Gender differences may influence decisions regarding utilization and timing of 

elective total joint replacement surgery in patients 

with moderately severe osteoarthritis of the hip or

knee. Men and women differ in their willingness to

accept continued functional decline, risks of surgery,

and disruption of usual role.6

Older women have higher rates of overall disability than men of the same age. This is because

Cochairs

Joan A. McGowan, Ph.D.

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases

National Institutes of Health 

Laura Lowe Tosi, M.D.

The George Washington University School of Medicine

Barbara Drinkwater, Ph.D.

Pacific Medical Center

Rapporteur: Joanna Taylor

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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

women survive longer with disabilities. In individuals

over 85 years old, 55 percent of women either require

help at home or live in a nursing home, compared 

with 37 percent of men. Even though white women

live an average of 7 years longer than white men, they

spend twice as many years disabled.7 Clearly, a focus 

of the women’s health agenda should be to prevent 

and delay the onset of disabilities in older women 

and to postpone the loss of independence and the 

need for nursing home admissions.

FIGURE 1a. Prevalence of leading chronic conditions causing limitation of activity, U.S., 1990-92.

0 2 4 6 8 10

Orthopaedic Impairments

Arthritis

Heart Conditions

Hypertension

Asthma

Diabetes

Disc Disorders

Mental Disability

Hearing Impairment

Visual Impairment

Cerebrovascular Disease

Paralysis

Emphysema

Persons (Millions)

Condition

Source: National Center for Health Statistics, National Health Interview Survey; National Heart, Lung, and Blood Institute, NHLBI FY 1996 Fact Book.

FIGURE 1b. Leading chronic conditions causing bed disability, U.S., 1990-92.

0 50 100 150 200

Orthopaedic Impairments

Heart Conditions

Arthritis

Asthma

Disc Disorders

Diabetes

Cerebrovascular Disease

Hypertension

Migraine Headache

Emphysema

Bed Days (Millions)

Condition

Source: National Center for Health Statistics, National Health Interview Survey; National Heart, Lung, and Blood Institute, NHLBI FY 1996 Fact Book.
“Today, no national system exists which can 

provide comprehensive information about injury 

and illness patterns in physically active women.”

Marjorie J. Albohm, 

M.S., A.T.C.

The National Athletic 

Trainers Association

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Osteoporosis is a condition involving low bone

mass and microarchitectural deterioration of bone 

that leads to an increased risk of fracture. The World

Health Organization has developed a quantitative 

definition of osteoporosis, with less severe bone 

deficits referred to as osteopenia. The definitions are

based on comparison of an individual’s bone density

with that of young normal individuals. Those whose

bone density is 2.5 standard deviations below normal

have osteoporosis and a markedly increased risk of

fracture. Low bone density is more prevalent in 

women than men because women accumulate less

bone at skeletal maturity and experience increased

bone loss due to estrogen deficiency at menopause.

Estimates indicate that in women over 50 in the 

United States, 13 to 18 percent, or 4 to 6 million, 

have osteoporosis, and 37 to 50 percent, or 13 to 

17 million, have osteopenia.8 The percentage of

women in the population with osteoporosis increases

with each decade of life after age 50 (see Figure 3). 

The decreasing bone density in these women is 

highly predictive of future fractures, especially at 

the hip.9 Health expenditures attributable to osteoporosis have been estimated to be $11 billion in 

older women annually in the United States.10

Orthopaedic problems represent the primary 

cause of bed disability in the United States and, 

in addition, are a top cause of limited activity (see 

Figure 1). In the United States, musculoskeletal 

impairments occur at a rate of 124 per 1,000 persons. Back or spine conditions are the most common, accounting for 52 percent of the impairments.

Over a 10-year period, a woman 65 years old has 

a 40 percent chance of being hospitalized for a 

musculoskeletal condition.11 According to the 

National Center for Health Statistics, women 

made more than 20 million visits to physicians 

for musculoskeletal conditions in 1995.12

0

10

20

30

40

50

60

■ Have Arthritis, but not limited by it

■ Limited by Arthritis

Source: National Center for Health Statistics, Health 

United States, 1995.

45-64 Years of Age

Percent

65-74 Years of Age 75 Years of Age & Over

WOMEN MEN WOMEN MEN WOMEN MEN

FIGURE 2. Proportion of persons with

arthritis and proportion with limitations of

activities due to arthritis by age and sex:

United States, 1993-94.
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Lack of appropriate physical activity throughout life may potentially underlie some of the physical impairments manifesting with increasing age 

in women. Unfortunately, a sedentary lifestyle is 

common in the United States. Women engage in 

less exercise than do men, according to the Centers 

for Disease Control and Prevention (CDC), with 

30 percent of women sedentary versus 25 percent 

of men.13 The percentage of individuals engaging 

in no leisure-time physical activity is higher among

minority women and women with less education,

putting them at higher risk of many chronic diseases

and disabilities (Figure 4). Physical activity can, 

however, lead to sports injuries. With the onset 

of legislation 25 years ago to provide equal opportunity for young girls and women to participate 

in sports (Title IX), female participants in intercollegiate sports increased from 300,000 in 1972 

to more than 2.25 million participants today. Educators and researchers need to focus on the impact 

of sports on the female body and mind. The many 

special advantages to participation in organized 

sports are clear, but some cautionary notes 

need to be applied to the generic message to 

“get moving.” Excessive exercise can lead to 

a pattern described as the “female athlete triad,” characterized by disordered eating, amenorrhea, and osteoporosis.14 Certain sports injuries are now found to be

more common in women, including lower-extremity

injuries such as stress fractures in the pelvis and hip

and knee ligament injuries.15

During its deliberations, the working group 

noted a critical lack of data on the prevalence and 

incidence of many bone and musculoskeletal disorders in women, and particularly on treatment 

outcomes. Such information is basic to successful 

care and management of chronic conditions and 

for goal setting. Finally, the working group stated 

that effective information dissemination to both 

health care providers and patients would improve 

total patient care tremendously.

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

Progress over the last few years in the basic 

science, treatment, and management of bone and 

musculoskeletal disorders has been remarkable. 

The working group noted the following advances.

■ Osteopenia

■ Osteoporosis

50-59

Years of Age

Percent of Women

60-69

Years of Age

70-79

Years of Age 80 & Over

100

80

60

40

20

0

FIGURE 3. Prevalence of reduced hip

bone density among women 50 years of age

and over by age and severity: United States,

1988-91

NOTES: Osteopenia is defined as a bone mineral density 

1-2.5 standard deviations below the mean of white, nonHispanic women 20-29 years of age as measured in

NHANES III (Phase 1); osteoporosis is defined as a bone

mineral density value of more than 2.5 standard deviations

below the mean of young white, non-Hispanic women

(WHO expert panel).

Source: National Center for Health Statistics, Health, 

United States, 1995.
47

VOLUME 2

Arthritis and Musculoskeletal Disability

Basic science related to the pathophysiology of

arthritis has been advanced in the last several years. 

In addition, there has been enormous progress in

understanding the role of self-management in living

with arthritis. Specific advances in our knowledge 

of arthritis and its treatment and management 

include the following:

• The discovery of some of the effects of genetics 

and genetic mutations on arthritis.

• Better understanding of cartilage cell physiology,

matrix factors, and enzyme cofactors.

• Improvements in joint replacement surgery.

• Increased understanding of modifiable and 

nonmodifiable risk factors.

• The discovery that self care works and 

enhances self-efficacy. 

• Progress toward the goal to achieve a better 

quality of life and acceptance of impairment 

or disability in a wider range of the arthritic 

population.

• Exercise studies indicating beneficial outcomes 

for arthritis patients, including pain relief.

• Studies showing that weight loss improves

osteoarthritis.

• Reliable and validated tools for assessing 

functional capacity, activity limitations, 

psychological status, and quality of life.

• Programs monitoring longitudinal outcomes 

in arthritis.

Osteoporosis and Fractures

During the last 6 years, there have been huge

advances in understanding the biology of bone 

remodeling and functions of various cells in the 

skeleton. In addition, new treatment options and

sophisticated assessment technologies are now available. Recent progress in understanding how calcium

and physical activity affect bone health includes 

(a) an NIH Consensus Development Conference 

in 1994 on optimal calcium intake; (b) new dietary 

guidelines for calcium intake;16 (c) the role of exercise and fall prevention in preventing osteoporotic 

fractures; and (d) the relationship between calcium

■ Non-Hispanic White

■ Non-Hispanic Black

■ Hispanic

Source: National Center for Health

Statistics, Heath, United States, 1995.

All Levels

Percent of Women

Less than 12 Years 13 or More Years 12 Years

60

50

40

30

20

10

0

FIGURE 4. Prevalence of

sedentary lifestyle among

women 25 years of age and

over by race, Hispanic origin,

and years of education: 

United States, 1991.
48

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

intake, physical activity, hormonal balance, and bone

mineral density in adolescents. Following are additional examples of advances in our knowledge of osteoporosis and its treatment and management:

• Biochemical markers of bone formation and 

resorption to identify fast “losers” and to 

monitor therapy.

• Ongoing prospective trials of large populations 

to identify risk factors and treatment effects. 

These include the Study of Osteoporotic Fractures, a prospective observational study of the 

risk factors for fractures, and the Women’s Health

Initiative, a large clinical trial testing the effect 

of hormone replacement therapy and diet on 

cardiovascular, cancer (breast and colon), and 

fracture outcomes.

• Diagnosis of osteoporosis and the assessment 

of fracture risk including (a) a new generation 

of bone mass measurement devices: dual-energy 

x-ray absorptiometry (DXA), ultrasound, quantitative computed tomography (QCT), and peripheral

computed tomography; (b) the World Health 

Organization criteria for evaluating results of 

bone mineral density tests to diagnose osteopenia

and osteoporosis; and (c) development of more

diverse normative databases, particularly the 

availability of the NHANES bone mineral 

density data.

• New pharmaceutical agents for prevention and

treatment — women now have choices other 

than HRT, including bisphosphonates, selective

estrogen receptor molecules, nasal calcitonin, 

and others on the horizon.

• Recognition that many new therapies for other 

diseases have long-term consequences on bone.

• Better understanding of the role of falls in fracture. Preventing falls and reducing the impact 

energy of a fall can prevent hip fractures in 

the elderly.

Orthopaedics and Physical Activity

Total joint replacements have provided enormous

relief from pain and disability for individuals with 

end-stage joint disease. Similarly, improved fracture 

fixation techniques and surgical techniques for soft 

tissue injuries have returned people to work and 

sport activity quickly. Following are some examples 

of advances in our knowledge and treatment of 

orthopaedic problems.

• Development of arthroscopic (less invasive) 

procedures.

• Bioengineering — repair of soft tissue and 

cartilage with biological materials.

• Distal radius fractures: (a) better recognition 

of the importance to patients of post-injury 

function and (b) more aggressive treatment 

to improve results.

• Recognition of carpal tunnel syndrome and 

some of the factors that may predispose to 

this condition.

• Improved technology and techniques for 

surgical repair for spinal deformity reducing 

the need for casting.

• Better recognition of the progression of osteoarthritis of the hand, which is much more 

common in women.

GAPS IN KNOWLEDGE

The advances of the last several years encourage

renewed focus on the gender-related issues of bone 

and musculoskeletal disorders.

Arthritis and Disability

Gender Differences. Research is needed to better

understand why arthritis is more common in women.

The most significant gap in research about arthritis 

in women is the role of genetic makeup and hormones in a woman’s autoimmune system and in 

the progression of inflammatory arthritis. In addition,
“. . . women’s health issues are long on numbers,

large on disability and suffering, and enormous in 

cost. To reduce suffering and disability, we need to 

prevent these disorders when we can, diagnose them

early to minimize their impact, and provide interventions to maximize functioning in patients who 

have them. We want our daughters and their 

daughters to travel a different road than we have.”

Lauri Tosi, M.D.

American Academy of 

Orthopaedic Surgeons

49

VOLUME 2

greater scrutiny is warranted for gender-related 

structural and biomechanical factors that predispose 

to osteoarthritis in women.

Biological and Mechanical Factors. Biological 

and mechanical factors that influence the onset and

progression of arthritis should be studied, including 

(a) biologically and socially indicated gender differences; (b) mechanisms of tissue destruction, assessment, intervention, and treatment; and (c) putative

prevention or amelioration of symptoms. Such investigations should encompass the cellular, tissue, and

organ levels, include all joint components, and use 

the latest technological advances in assessment.

Repair Processes. Research should address 

the possible early biological repair process in

osteoarthritis with attention to the role of growth 

factors, among others, that would prevent late 

changes that lead to joint replacement. Prospective

clinical trials should be conducted for various surgical procedures designed to stimulate repair of

osteoarthritic joints.

Risk Factors. Modifiable risk factors should be a

target for research initiatives. What is the relationship

of weight, diet, and lifestyle to the development of

osteoarthritis? The environmental impact on development of osteoarthritis should be investigated as well.

Racial Differences. Racial as well as socioeconomic differences in osteoarthritis prevalence 

need study. Poor socioeconomic status and female 

gender lead to late treatment, which in turn 

increases the morbidity of arthritis.

Quality-of-Life Issues. Research must be done 

to develop outcome measures that have meaning for

women with a chronic disease such as arthritis and

must include a measurement of functional status and

an assessment of their quality of life. Depression is

common in women with arthritis, for example. These

outcomes must be realistic and relevant to women’s

lives. The role of self-management in outcomes, methods to maintain patient function, and the art of longterm care are all important subjects for study. The 

techniques developed for self-efficacy in arthritis 

care and management could be applied to other 

chronic conditions such as low back pain.

Exercise. The role of exercise in arthritis pain

management is important. Science should be applied 

to exercise prescriptions with regard to behavioral

modification to enhance adoption and maintenance 

by patients.

Treatment and Rehabilitation. Federal support needs to be applied to answer questions about 

alternative and complementary therapies for arthritis.

Patients spend a great deal of money on untested 

therapies. Several alternative therapies for arthritis 

have become popular, such as cartilage transplants,

injectable lubricants (hyaluronic acid), acupuncture,

and oral glucosamine and chondroitin sulfate, which

are advertised as the “arthritis cure.” 

Arthritis of the Basilar Joint of the Thumb. 

The major thrust, to date, has been in treating the

underlying condition rather than prevention or 

better understanding of the basis of the disorder. 

More research efforts need to be directed at under-
50

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

standing the pathophysiology: (a) initial causes 

of the disease (i.e., why is this joint so lax that it 

deteriorates?); (b) identification of women who 

could benefit from early (presymptomatic) treatment;

and (c) continued examination of surgical treatment

options, that is, better soft-tissue arthroplasties or 

total joint replacements so that rehabilitation is 

less difficult.

Other Arthritic Conditions. Less common 

arthritis conditions need further study. Chronic

fibromyalgia is poorly diagnosed, misdiagnosed, 

and overdiagnosed. Musculoskeletal manifestations 

of Lyme disease can be better diagnosed and treated.

Temporomandibular disorders in women during the

reproductive years need investigation with regard to

their central nervous system component.

Osteoporosis and Fractures

Peak Bone Mass Development. Factors 

that affect attainment of peak bone mass in young 

women need to be studied, including diet, exercise,

hormonal, and environmental factors. Many young

women are misinformed about their likelihood of

developing osteoporosis. The effects of physical 

activity, calcium, delayed menarche and menstrual

cycle irregularities, dieting and eating disorders, 

pregnancy, and smoking and alcohol consumption

must be investigated. Recent retrospective studies 

indicate a positive correlation between milk consumption and calcium intake during adolescence 

and young adulthood and bone density in middleaged and older women; thus, lifelong prospective 

studies need to be conducted to determine the 

effects of childhood calcium intake on peak bone 

mass. Questions relating to the role of skeletal 

osteopenia during the growth spurt in contributing to the rising incidence of bone fragility fractures 

during puberty need to be addressed. Finally, factors

leading to development of peak bone mass in different sexes, races, and under different conditions 

require study.

Perimenopause. Women’s age at onset of bone 

loss needs further study. Is there significant bone 

loss in the perimenopausal years? Bone “losers” 

need to be characterized and the causes determined.

Do genetics or lifestyle contribute to early bone loss?

Ways to maintain bone mass during the premenopausal years need to be identified. Should hormone

replacement therapy start earlier to offset this?

Therapy with Pharmaceutical Agents and 

Hormones. The working group addressed a number 

of research needs in osteoporosis therapy:

• Effect of combination therapies on prevention and treatment. We need human research 

on the incremental effectiveness and safety 

of combination therapies. These combinations include simultaneous administration 

of calcium, vitamin D, male and female 

hormones, and bisphosphonates or other 

pharmaceutical agents.

• Continued development of new selective 

estrogen receptor molecules (SERMs).

• Determination of optimum vitamin D status. 

Will optimizing vitamin D status reduce the 

fracture burden? How much vitamin D do 

typical adults normally produce in their 

own skin every day — summer and winter? 

What is the interaction between vitamin D 

status and dietary calcium? An inexpensive, 

reliable, and effective vitamin D preparation 

is needed. Studies should be conducted 

in minority groups to determine the extent 

of vitamin D deficiency and osteoporosis.

• Development of fluoride formulations that 

are safe and effective to manage patients who

already have osteoporosis and to rebuild bone 

mass of individuals who are osteopenic but 

have not yet fractured.

• Clinical trials of current approved interventions 

on women of various races, ethnicity, ages, and

estrogen status; explore the impact of ethnic 

differences in lactose intolerance on calcium 

balance and fracture risk.
51

VOLUME 2

• Development of anabolic agents to rebuild 

bone connectivity as well as density.

• Better understanding of long-term effects of 

new therapies on bone. Better understanding 

of the effects of drugs that stabilize bone mass 

by limiting bone resorption or enhancing 

bone formation.

• Pain and deformity management.

• Absolute and relative rates of bone formation 

and bone resorption may vary across individuals.

Which treatment options are best for patients 

presenting with various combinations of 

these factors?

• Improved methods of bone fixation following

osteoporotic fractures.

• Use of mechanical and electromagnetic forces 

in stimulating increased bone mass.

• Role of progesterone in skeletal development 

and maintenance.

• Development of growth factor strategies to 

enhance fracture repair.

Exercise. Research should be conducted to 

study the effects of exercise on bone and muscle 

health across the life span. Exercise may have a 

critical role in the development of peak bone mass 

by providing optimal mechanical stimulation. In addition, exercise in childhood and early adulthood may 

set up good behavioral patterns for life. Research is

required to optimize behavioral strategies to encourage exercise. Research to determine how specific 

forms of exercise affect the risk of fracture would 

be welcome. The effects of exercise are likely to be 

site-specific and variety is likely to be necessary to 

optimize positive effects on bone quality. In addition,

the role of exercise in attenuating bone loss and the

role of physical fitness (strength, balance, coordination) in preventing falls and enabling women to 

remain active as they age should be studied.

Screening Methods. More reliable and inexpensive densitometry techniques for earlier intervention

should be developed to improve patient quality of life.

Normative bone density values for children are needed.

Racial, Ethnic, and Minority Groups. Several

research areas need more attention. Why is osteoporosis more common in the female white and Asian populations, what triggers it, and what role do risk factors

play in its progression? Ethnic (genetic) differences in

bone mineralization metabolism (genetic, molecular)

should be investigated. Bone density norms should be

established for minority groups. Effectiveness of therapies should be ascertained for minority groups as well.

Postmenopausal Years. Relationships between

osteoporosis and important diseases of postmenopausal women — breast cancer, depression, rheumatoid arthritis, stroke, and coronary heart disease —

need to be explored. Also needing study are the 

variations in absolute and relative rates of bone 

formation and bone resorption across individuals.

Research needs to determine which treatment 

options are best for patients presenting with various

combinations of these rates. Another area of study 

is the impact of sarcopenia (muscle loss) on aging

women and its relationship to falls.

Quality-of-Life Issues. Psychosocial and qualityof-life studies are needed, focusing on loss of family

role, fear of falling, pain, and depression.

Fractures. Osteoporosis does not equally affect

bones in a given individual or across individuals.

Although the major fracture sites are at the wrist, 

the hip, and the spine, it is not clear why bones 

are affected differentially in a “systemic” disorder. 

Some of this may be related to the protective effect 

of physical activity and loading. Fall prevention and

frailty leading to fractures are subjects that need more

study. Attempts to identify and analyze the incidence

and reasons for falls leading to osteoporotic fractures 

must be encouraged. Colles’ fracture should be 

studied as an indicator of osteoporosis and future 

hip fractures. Although the medical community 

has begun to recognize that stress fractures may 
52

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

be the first signs of premature osteoporosis, little 

has been done to establish guidelines for further 

evaluation, treatment, and prevention of these injuries.

Methods of rehabilitation for frail elderly women who

have suffered fractures need to be explored.

Compliance. Bone loss can be prevented. Why 

do women stop taking the medication that can prevent

the loss? We need research on behavioral issues surrounding the widespread lack of compliance with 

well-known preventive and therapeutic measures 

in osteoporosis. 

Prevention. Research is needed to understand 

how best to educate the public about prevention 

of osteoporosis and osteoporotic fractures through 

diet and exercise. Motivational factors for increasing

calcium consumption and exercise in all ages (primary, secondary, and tertiary prevention issues) 

must be sought.

Basic Research. The working group listed the 

following basic research topics needing support:

• The biology of bone adaptation to mechanical 

loading, specifically the set point mechanism 

that senses loading and responds appropriately 

to control the skeletal adaptive response.

• Relationship between the mechanical stimulation 

of normal versus osteoporotic bone cells at the 

cell, tissue and organ level.

• Genetic influences for osteoporosis (receptors for

collagen, calcium, estrogen, vitamin D, cytokines).

Role of genetics in predisposing women to osteoporosis. Genetic studies on osteoporosis, including

but not limited to studies of the genetic linkage to

rates of bone loss.

• Role of testosterone in bone remodeling.

• Interaction of metabolic bone disease and 

depression.

• Role of smoking and alcohol consumption 

in bone homeostasis.

• Clinical application of biochemical markers.

• Importance of qualities other than quantity 

of bone in risk for osteoporotic fractures. 

• Inefficient repair of bone tissue micro damage.

• Interaction between estrogens and cytokines,

including research on estrogen action on 

bone, and identifying and isolating osteoclast 

precursor cells.

• The molecular basis for the cell-to-cell interaction that governs bone resorption and 

osteoblast activity in vivo. Effect of cell matrix

interaction in osteoblast and osteoclast proliferation and differentiation.

• Cellular mechanism of the anabolic affects of

parathyroid hormones, prostaglandins, and 

fluoride on bone.

• Transcriptional control of osteoblast differentiation.

Orthopaedics and Physical Activity

Cell Repair and Growth. We need to investigate

the molecular signals that control repair and growth 

in cells of the musculoskeletal system. Whether women

and men heal bone and cartilaginous tissues differently

should be studied, including the effects of estrogen and

other hormones on tissues at the cellular level and on

ligament tissues. Other areas in need of study include

stimulation of bone and wound healing, particularly

the effect of ultrasound, and relaxants that cause

changes in cartilage.

Synthetic Tissue Replacements. Biologically

based repair procedures should be developed as alternatives to joint replacements. Synthetic replacements

for muscle, soft tissue, and bone damaged beyond

repair are needed as well.

Criteria for Surgical Repair. The development 

of arthroscopic surgical techniques should lead to 

less invasive surgeries and better outcomes. There is 

a need for studies that demonstrate the advantage of

surgical repair on the natural history of the joint. 
“Clinical studies are needed to acquire information about the natural history of [Paget’s disease], 

the incidence of fracture, and other complications

including the neuropsychiatric manifestations. Also,

greater insight into the relationship between the 

hyperparathyroid process and postmenopausal 

bone loss is essential.”

Charlene Waldman

53

VOLUME 2

Feet. Further studies are needed about the 

relation of poorly fitting shoes to foot problems and

deformities. Long-term wear of high heels is a concern.

Another goal is to identify the best types of shoes (a)

for children and adolescents for long-term foot health

and (b) for the elderly so as to prevent falls. The longterm effects on the feet of enhanced participation in

athletics and physical fitness among women should 

be investigated. What are the mechanisms for progressive foot deformity in women with aging. Finally, 

additional research is needed to better understand 

the effects of diabetes, rheumatoid arthritis, and 

pregnancy on the feet.

Stress Fractures. Stress fractures are common 

in the elderly and in athletes. The genetic implication 

and etiology of stress fractures need study. How do 

we improve training techniques to prevent stress fractures and overuse injuries in athletes? How do these

injuries differ from stress fractures in the elderly?

Role of Immune System. We need to enhance 

our ability to manipulate the body’s immune system 

to increase successful transplantation of donated 

bones and ligaments.

Total Joint Replacement. Total joint implants 

fail with increasing frequency after 10 to 15 years.

Improved implant development is critical for the 

aging population. Research should investigate how

wear particles from total joints affect implant failure.

Women receive 60.5 percent of total hip replacements

and 62.5 percent of total knee replacements. Gender

differences in preference for surgical replacement 

need further scrutiny. The interaction of bone loss 

and implant loosening needs further study. Can 

agents that inhibit bone loss such as bisphosphonates

prevent some implant loosening? What is the effect 

of postmenopausal estrogen use on the stability of 

joint replacement implants? Bone health after total 

joint replacement needs further study as well.

Shoulder Instability and Loss of Motion. Prevention and treatment of instability in the shoulder

depends on increased knowledge about the biochemical and cellular pathways involved in the development

of generalized ligamentous laxity. Researchers need 

to determine why there is female predominance of

multidirectional instability. The role of estrogen balance

in the pathophysiology of adhesive capsulitis (frozen

shoulder) has yet to be determined. Research should

focus on why the condition primarily affects women

ages 40 to 60 — its relation to menopause, relation 

to hormones, and vasculitic etiology. Additional 

clinical and basic research is needed on the glenohumeral ligaments of the female shoulder and 

proper rehabilitation.

Breast Cancer and Bone. Two recent prospective

studies have indicated that women with high bone

density are more likely to develop breast cancer than

women with low bone density. One factor that may 

be common to both is the total lifetime exposure to

endogenous estrogen — with high exposure to estrogen promoting optimal bone mass retention but 

potentially increasing the risk of breast cancer. 

These observations need clarification and extension.

Trading healthy bones for healthy breasts presents 

a dilemma that must be resolved.

Breast cancer often metastasizes to bone. More

research initiatives are needed in the area of orthopedic oncology, including research on complex 

interactions between tumor cells and host bone cells. 
54

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Chemotherapy, radiation, and surgery for breast

cancer often result in bone and muscle loss; research

into therapies that prevent these losses is needed. 

Continued progression of research initiatives in the 

area of biomechanics research revolving around 

design of implants as well as design of fracture fixation devices is critical to allow optimum recovery 

of function in patients who have developed fractures 

or significant metastatic lesions, particularly following breast cancer.

Development of endocrine therapies for 

treatment of metastatic lesions depends on a 

better understanding of bone cell metabolism 

and response of both normal bone cells and tumor

cells to these therapies. It will be essential in the 

future to develop local delivery systems for chemotherapy and radiation sensitizers to improve local 

benefit while reducing systemic effects of these 

potentially dangerous but critical modalities. 

Research into the causes of bone pain and the 

cellular mechanism of transmission of bone pain 

will help to reduce and manage bone pain in 

women with metastatic breast cancer. Studies of 

the adverse effects of drugs used in treatment of

metastatic breast cancer and ways to prevent such

adverse effects in the treatment of metastatic breast

cancer are critical to prevent injury and to improve

function in patients with the disease.

Carpal Tunnel Syndrome. The pathophysiology 

of carpal tunnel and other repetitive stress syndromes

is not clearly understood and deserves further study.

This condition should be researched at the cellular 

and physiologic levels — for example, the reasons for

flexor tenotynovium hypertrophy. The relationship 

of carpal tunnel syndrome to physical fitness and 

activity should be investigated and interventions 

developed and tested. Prevention of carpal tunnel 

syndrome must be a research priority.

Hyperparathyroidism. Greater insight into the 

relationship between hyperparathyroidism and postmenopausal bone loss is needed. Information is also

needed on the course of patients who undergo parathyroid surgery as well as those who are followed 

conservatively. Additional studies will help to clarify

currently accepted guidelines for surgery versus 

medical management for primary hyperparathyroidism. Also, research is needed to study possible 

medical therapies.

Wrist Fractures. Distal radius (wrist) fractures 

have been treated with benign neglect in the past.

Orthopedists fail to see them as a warning sign of

osteoporosis. Treatment is still imperfect despite 

SRS (a bone cement injected into the fracture site 

that enables activity right away). Areas to be improved

include better prevention of falls, wider dissemination

of treatment advances, and greater efforts to perform

osteoporosis workups in wrist fracture patients to 

vigorously prevent other fractures.

Scoliosis. While mild scoliosis is equally 

prevalent in males and females, more severe spine 

curvature is eight times more common in adolescent 

females. Research is needed to determine the etiologic

factors involved in the progression of mild to moderate and severe scoliosis in females. Outcome studies 

are needed to identify the best treatment strategies.

Investigation into the association between scoliosis 

and osteoporosis is warranted. 

Physical Activity. Definitions of exercise are 

framed around men’s activities. The type, intensity,

duration, and frequency of physical activity that is

important for musculoskeletal health in women must

be researched. The role of physical activity in the

development of bone, tendon, ligament, and muscle 

is poorly understood. What is the interrelationship 

of mechanical environment and cellular function? 

We know that increasing load increases bone mass, 

but what increases cartilage? In addition, we need 

to study the impact of musculoskeletal fitness on

comorbid disease progression.

Leisure-time exercise needs to be compared 

with household or occupational activities. Is there 

a difference in hormonal response to recreational 

versus work-related exercise? 
55

VOLUME 2

Clear standards for physical activity are needed 

for various populations. Populations with chronic 

diseases need special exercise programs. Differences 

in inactivity and maintenance of exercise in cultural

and economic groups should be explained. Advanced, 

technically assistive, cost-effective devices should 

be developed for the elderly with musculoskeletal 

disorders. The role of physical activity in rehabilitation needs more emphasis to prevent disability and

institutionalization of those who have fractured hips

from falls, for example. Potential intervention with

physical activity to prevent decline in these patients

should be further investigated.

Muscle Biology. Marked losses of muscle mass

occur with aging (and inactivity) and yet little research

has focused on the role of muscle in impaired mobility,

increased risk for falls and hip fractures, and inability

to perform everyday activities. Women have lower

muscle mass and higher body fat content than men

throughout life. Moreover, aging can be associated 

with dramatic shifts in body composition, leading 

to increases in overall body fat and abdominal fat. 

Such changes in body fat and its distribution are

thought to be important in the onset of disorders 

commonly noted in older persons, such as insulin

insensitivity and cardiovascular disease. As the size 

of the aging population grows, there will be a greater

need for ways to reduce or even prevent the physical

disabilities and metabolic consequences of decreased

muscle mass and increased body fat. Both clinical and

animal findings to date indicate that the underlying

pathophysiology of physical disabilities and metabolic

disorders may range from a sedentary lifestyle to agerelated changes in the intrinsic properties of skeletal

muscle. To develop optimal intervention programs, 

further research will be needed on the qualitative 

and quantitative relationships between changes in 

muscle and body composition and the functional 

and metabolic status of older women.

Sports Medicine. The “female athlete triad” is 

a term describing a condition common in female 

athletes that combines premature osteoporosis, 

menstrual irregularity, and eating disorders. This 

condition needs investigation, including contributing

factors such as nutrition, energy expenditure, and

stress. Research and education are needed to better

train coaches and doctors to recognize the female 

athlete at risk for developing female athlete triad 

to enable appropriate modifications to training programs. Exercise preparation and training for sports 

are based on a male model, and current practices 

may predispose women to injury. Do women predispose to injuries during different phases of the 

menstrual cycle? Women athletes need appropriate 

muscular techniques and endurance throughout 

life to prevent sports injuries.

The causes of anterior cruciate ligament (ACL)

injury and other common injuries of female athletes

should be identified to enable development of adequate prevention programs. More research to 

delineate the physiological differences between 

female and male knee stabilization patterns during

sports movements is critical. It is unknown whether

cellular biochemical or physiologic responses to 

injury and tissue repair differ in men and women, 

and further research is critical in this area. Because

estrogen has a direct effect on collagen synthesis 

and because neuromuscular performance is also 

known to vary during the menstrual cycle, it is 

logical to question whether the female menstrual 

cycle has an effect on injury rates.

Continued research on devices and surgical 

technique improvements will enhance patient care 

and facilitate an earlier return to function. In addition,

the basis for gender differences in treatment should 

be explored: what is effective, why outcomes in men

and women differ when receiving the same treatment,

and what mechanisms underlie these differences.

Data Needs and Information Dissemination 

In discussing and developing the agenda 

of research gaps and opportunities in bone and 

musculoskeletal disorders, the working group 

identified data collection as one overarching area 

of need. So that we may understand the impact 

of research initiatives on the specific diseases 
56

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

and conditions under discussion, we must have 

a way to track progress. To assess the prevalence 

and incidence of the bone and musculoskeletal 

conditions, the working group relied on data from

national surveys like the National Health Interview

Survey and the National Health and Nutrition 

Examination Survey. These and other national 

data sets need to expand the questions related 

to the musculoskeletal system.

Information on Prevalence and Treatment 

Outcomes. The Behavior Risk Factor Surveillance 

Survey administered through the CDC’s National 

Center for Chronic Disease Prevention could add

arthritis and musculoskeletal conditions to its 

core set of questions. Comparative arthritis data 

are needed, including a better understanding of 

arthritis risk factors, the impact of behavior changes 

on pain and disability, and the effectiveness of interventions. Better estimates of the economic consequences of arthritis in women — particularly 

indirect and intangible costs — should be developed. Other prevalence and treatment outcome 

data are lacking, including:

• Normative range of musculoskeletal changes 

in aging.

• Impact of socioeconomic status on musculoskeletal diseases.

• Environmental agents’ effect on organ system 

development, long-term consequences.

• Clinically useful outcome measures (not just 

of accuracy) that acknowledge the validity of

patient measures for functional outcomes.

• Effects of cancer and its treatment on muscle 

mass and bone; how to counteract.

• Effects of transplants on muscle mass and 

bone; how to counteract.

• Musculoskeletal injuries caused by violence 

so as to improve recognition by care givers.

Sports Injury Surveillance. With exercise 

increasingly recommended to prevent or improve 

a myriad of health problems, doctors are seeing 

new and worrisome injury patterns. However, there 

are no data on the prevalence of such injuries that

could be used to study their connection to longterm disability. To prevent activity-related injuries, 

minimize their effect, and ensure a safe participation

environment for physically active females, a nationwide injury surveillance system designed to document, track, and monitor the injury and illness 

patterns of this population must be established. 

Only when injury and illness patterns are identified

can appropriate preventive interventions be developed and implemented. Information relating to 

injury and illness patterns, prevention, and management is essential to encouraging females to become

physically active and to remain committed to a 

physically active lifestyle.

Instruments to Measure Physical Activity and 

Outcome. Instruments to measure physical activity 

in women from childhood through later adulthood

should be developed and validated and related to

women’s functional and health outcomes. Good performance measures are lacking for the musculoskeletal

system; such measures should be highly scaled. An

understanding of the relationship between structure,

function, and ultimate outcome will strengthen prevention efforts. The rehabilitation field needs instruments — preferably questionnaires or personal 

interviews — for measuring physical activity in 

disabled women. These instruments should address

specific disabilities and correlate multiple objective 

and subjective factors.17

Tracking and Improving Compliance. Methods 

are needed for tracking and improving compliance

with effective therapies. Patient compliance with 

therapies for bone and musculoskeletal problems is

poor, even though patients suffer from these problems

universally and complain about them more than any

other health problems. For example, women are more

aware of osteoporosis than heart disease but do not
57

VOLUME 2

take action to prevent or counteract it. Investigators

should identify effective ways to encourage women 

to increase exercise throughout the life span. How 

do we teach physicians to encourage their patients 

to make lifestyle changes? How can medical prescriptions be incorporated into daily life? The role of the

patient in self-management of chronic bone and 

musculoskeletal conditions must be better described.

For example, cancer patients and transplant recipients

need education and instruction on how to counteract

the adverse effects on muscle mass and bone.

RESEARCH 

RECOMMENDATIONS

The working group made the following 

recommendations at the Beyond Hunt Valley 

meeting in November 1997.

Arthritis

• Investigate the greater prevalence of arthritis 

in women and its triggers. 

• Explore the biological and mechanical factors 

that influence the progression of arthritis.

• Examine biological repair processes and bioengineering approaches to tissue regeneration.

Osteoporosis

• Understand the factors that contribute to the 

development of peak bone mass (e.g., diet, exercise, puberty, pregnancy, smoking, environment).

• Focus on clinical trials to develop treatment 

and prevention studies that will not be conducted by the private sector — combined 

drug therapies, exercise, nutrition studies.

• Further refine biological markers and other 

assessment technology.

• Focus on maintenance of bone mass throughout

life — identify genetic and lifestyle factors 

associated with bone loss.

• Explore quality-of-life issues in women with 

osteoporotic fractures.

• Explore the role of physical activity in preserving

muscular strength, balance, and coordination as 

a means of preventing falls in the elderly.

• Develop specific exercise regimens that affect 

the bone at the major sites of fracture (hip, 

spine, and wrist).

Orthopaedics

• Investigate the role of women’s footwear in pain,

disability, and falls.

• Determine the prevalence and etiology of stress

fractures and other overuse syndromes — 

repetitive stress injury.

• Investigate the molecular signals that control 

repair and growth in cells of the musculoskeletal system.

• Develop synthetic replacements for muscle, 

soft tissue, and bone damaged beyond repair.

• Explore knowledge of the interaction of the

immune system and its role in transplantation 

of bone and ligaments.

• Study the relative influences of osseous anatomy,

ligamentous laxity, and sex hormones on musculoskeletal disorders.

• Explore gender variation in treatment outcomes.

Physical Activity and Sports Medicine

• Improve measures of energy expenditure and 

its benefits to the musculoskeletal system — 

does leisure time exercise play a different role 

from household or occupational activities?

• Determine the type, intensity, duration, and 

frequency of physical activity that is important 

for musculoskeletal health.
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

• Investigate gender differences in sports injuries 

— endocrine, structural, and training factors 

that lead to injury.

• Explore the “female athlete triad,” including 

contributing factors such as nutrition, energy

expenditure, and stress.

• Understand the role of physical activity in 

the development of bone, tendon, ligament, 

and muscle.

Data Needs and Information Dissemination

• Provide information from national data 

surveys and large cohorts on prevalence 

and treatment outcomes.

• Improve surveillance of injury patterns in 

physically active women of all ages.

• Improve, develop, and validate instruments 

that measure physical activity and relate it 

to health outcomes — improved performance measures.

• Develop effective information dissemination processes.

• Develop methods for tracking and improving 

compliance with effective therapies.

References

1 FDA Consumer, March 1996.

2 National Center for Health Statistics, National Health

Interview Survey, National Heart, Lung, and Blood 

Institute, NHLBI FY1996 Fact Book.

3 Ettinger WH, Burns R, Messier SP, Applegate W, Rejeski

WJ, Morgan T, Shumaker S, Berry MJ, O’Toole M, Monu J,

Craven T. A randomized trial comparing aerobic exercise

and resistance exercise with a health education program 

in older adults with knee osteoarthritis. The Fitness 

Arthritis and Seniors Trial (FAST). JAMA 1997;227:25-31.

4 Callahan LF, Rao J, Boutaugh M. Arthritis and women’s

health: prevalence, impact, and prevention. Am J Prev 

Med 1996;12(5):401-9.

5 Centers for Disease Control and Prevention. MMWR 

Morb Mortal Wkly Rep 1995 May 5;44(17):329-34.

6 Karlson EW, Daltroy LH, Liang MH, Eaton HE, Katz JN.

Gender differences in patient preferences may underlie 

differential utilization of elective surgery. Am J Med

1997;102(6):524-30.

7 Guralnik JM, Leveille SG, Hirsch R, Ferrucci L, Fried LP.

The impact of disability in older women. J Am Med 

Womens Assoc 1997;52(3):113-20.

8 Looker AC, Orwoll ES, Johnston CC Jr, Lindsay RL, 

Wahner HW, Dunn WL, Calvo MS, Harris TB, Heyse SP.

Prevalence of low femoral bone density in older U.S. 

adults from NHANES III. J Bone Miner Res 1997

Nov;12(11):1761-8.

9 Black DM. Why elderly women should be screened 

and treated to prevent osteoporosis. Am J Med 1995 

Feb 27;98(2A):67S-75S. 

10 Ray NF, Chan JK, Thamer M, Melton LJ 3rd. Medical

expenditures for the treatment of osteoporotic fractures 

in the United States in 1995: report from the National

Osteoporosis Foundation. J Bone Miner Res 1997

Jan;12(1):24-35.

11 Praemer A, Furner S, Rice D, editors. Musculoskeletal 

conditions in the United States. Park Ridge, IL: American

Academy of Orthopaedic Surgeons, 1992.

12 National Ambulatory Medical Care Survey. 

13 Centers for Disease Control and Prevention, National 

Center for Health Statistics, National Health Interview 

Survey, 1991.

14 Nattiv A, Agostini R, Drinkwater B, Yeager KK. The 

female athlete triad. The inter-relatedness of disordered

eating, amenorrhea, and osteoporosis. Clin Sports Med

1994 Apr;13(2):405-18.

15 Teitz CC, Hu SS, Arendt EA. The female athlete: 

Evaluation and treatment of sports-related problems. 

J Am Acad Orthop Surg 1997;5:87-96.

16 Standing Committee on the Scientific Evaluation of 

Dietary References, Institute of Medicine Report. Dietary

Reference Intakes: Calcium, Phosphorus, Magnesium, 

Vitamin D, and Fluoride. National Academy Press, 1997.

17 Gerber LH, Furst GP. Scoring methods and application of the activity record (ACTRE) for patients with 

musculoskeletal disorders. Arthritis Care Res 1992

Sep;5(3):151-6.
CANCER

BACKGROUND

Cancer remains a major public health problem, causing untold anxiety and suffering for patients and their families and generating a substantial part of the nation’s health care expenditures. In 1997, an estimated 596,000 women were

diagnosed with cancer, and 265,900 women died of

the disease.1 Cancer is the leading cause of death for

35- to 74-year-old women. It is only after age 75 that

heart diseases cause more deaths among women than

cancer. Lung cancer continues to be the leading cause

of cancer deaths for women, followed by breast and

colorectal cancers. (This varies by geographic region; 

in some regions breast cancer is more common than

lung cancer.) 

Although outcomes after cancer diagnosis vary

widely by age, ethnic background, and socioeconomic

status and the survival data for women of color remain

poorer than for white women, cancer mortality rates

are falling for some populations of women. Longterm medical, sexual, reproductive, and psychological health need to be addressed in women who 

are cancer survivors.

Since 1991, enrollment in health maintenance

organizations and other managed-care organizations

has increased dramatically. Cancer patients now 

report difficulties in gaining referrals to the appropriate specialists, and in gaining access to NCI-sponsored

cancer trials, treatment at NCI-designated cancer centers, and programs for cancer survivors. Changes in

reimbursement limit investigator time and institutional monies available to support basic and clinical

research. These changes, together with the persistence

of a large portion of the population without health

insurance, are having a major impact on basic and 

clinical cancer research and the quality of patient care.

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

The major development since the conference 

held on women’s health at Hunt Valley, Maryland, 

in 1991, is the decrease in the U.S. cancer mortality

rates. For women, these advances represent primarily 

a decrease in mortality for breast and colorectal 

cancers among white women. Lung cancer mortality 

is decreasing in men, but increasing in women. Very

little progress has been made to improve survival 

from gynecological tumors. In 1991, the Hunt Valley

report projected that 22,500 women would die of 

ovarian, cervical, and uterine cancers. In 1997, 

this estimate has risen to 28,200 deaths.1

In the interval since Hunt Valley, major advances

in genetics have improved the scientific understanding of cancer. Genes that account for 5 to 10 percent 

of cancers of the breast, endometrium, and ovary 

have been identified and sequenced. These percentages will probably increase as other genetic factors 

are identified. In addition, the genetic and signaling 

pathways responsible for the loss of normal cellular

control mechanisms have improved our understanding

Cochairs

Edward Trimble, M.D., M.P.H.

National Cancer Institute

National Institutes of Health 

Karen Antman, M.D.

Columbia University

Rapporteur: Jean Sevin, Ph.D.

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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

of carcinogenesis in sporadic (or nonfamilial) cancers.

Furthermore, similar changes in oncogenes and tumor

suppressor genes occur across many cancers, suggesting common mechanisms of loss of cell cycle control. 

Identification of specific genes that increase an

individual’s risk of cancer has occurred faster than 

protective legislation and advances in screening 

methods and therapy to improve long-term survival.

Persons now identified as having a high risk of cancer face personal uncertainty and potential discrimination in health care coverage and employment. 

This lack of synchronism in research and medical 

legislation raises serious medical, social, ethical, 

and legal questions about screening for genetic 

abnormalities and demonstrates the need for 

improvements in screening and treatment. 

Since 1991, the links between infection and 

some cancers have been extended. Associations

between Epstein-Barr virus, Burkitt’s lymphoma, 

and nasopharyngeal carcinomas; specific human 

papilloma viruses and cancers of the cervix and 

vulva; and hepatitis and hepatoma were already 

well established by 1991. However, recognition 

of the relationship of Helicobacter pylori to gastric 

cancer and of human herpes virus 8 (HHV8) to

Kaposi’s sarcoma is more recent. The observation 

that integration of the viral genome into the host 

DNA is necessary for carcinogenesis in some 

cancers suggests a mechanism for viral carcinogenesis in cancer etiology.

The idea that cancer may be a preventable 

disease is coming closer to reality. Recognition that

genetics, diet, cigarette smoking, hormones, and the

environment all influence cancer rates has led to 

small and large-scale cancer prevention trials. These

have included evaluation of retinoids to prevent 

skin, cervical, esophageal, lung, and head and neck

cancer, and tamoxifen to prevent breast cancer. The

COMMIT and ASSIST studies in tobacco cessation 

have shown strategies at the community level to

decrease tobacco use. Prevention strategies raise 

new questions regarding access to treatment, 

individual freedoms versus societal good, and 

acceptable side effects of treatments. 

Since 1991, research studies such as the NIH’s

Postmenopausal Estrogen/Progestin Interventions 

Trial have shown the benefit of long-term hormone

replacement therapy (HRT) in lowering the risk of 

cardiovascular disease.2 HRT may decrease risks of

osteoporosis, Alzheimer disease, and colon cancer. 

HRT has also been associated with increased risks 

of breast and endometrial cancer. Women and their

health care providers must carefully weigh the benefits

and risks of HRT based on currently available and

emerging data. 

Women’s health researchers now stress the 

importance of examining gender, socioeconomic, 

and racial and ethnic differences when studying 

cancer incidence, mortality, and cancer-related preventive health practices. This information has broadened our understanding of both similarities and 

differences in subgroups in the population. For 

example, compared with men, women develop 

lung cancer after lower doses and shorter intervals 

of cigarette smoking. Since the Hunt Valley conference, differences in metabolism that affect responses 

to carcinogens and to treatment have been observed

between women and men, between different racial 

and ethnic groups, and between older and younger

individuals. Research has begun to describe the interplay of genetic, environmental, socioeconomic, and

other factors that determine whether an individual 

will develop cancer and whether that cancer will

respond to treatment.

In the years since Hunt Valley, consumer 

advocates have become more involved in cancer

research. These groups have focused the nation’s 

attention on critical cancer issues, including prevention, education, screening, treatment, and 

survivorship, as well as the importance of laboratory research. They have supported their priorities 

for research and have become involved in the design

and conduct of prevention, screening, and treatment

trials. Consumer groups and cancer investigators 
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VOLUME 2

have also strengthened research on quality-of-life 

issues for those undergoing treatment and for survivors who have completed treatment. The National

Cancer Institute (NCI) has established a Consumer

Liaison Group in the Office of the Director and the

Office of Cancer Survivorship in the Division of 

Cancer Control and Population Science.

In this report, the working group addresses

remaining research priorities for the most common

malignancies affecting women, including cancers 

of the lung, breast, colorectum, ovary, cervix, and 

uterine corpus.

GAPS IN KNOWLEDGE

Lung Cancer

In 1997, the American Cancer Society estimated,

from the NCI’s Surveillance, Epidemiology, and End

Results (SEER) data, that 83,200 women were diagnosed with cancer of the respiratory system, and 

that 67,430 women died of respiratory cancer.3

These deaths represent 25 percent of all cancer 

deaths among women and an increase of more 

than 16,000 deaths since 1991.

The incidence of lung cancer varies by gender 

and ethnicity and follows historical patterns of 

smoking. In 1994, the incidence of lung cancer 

per 100,000 individuals was 43 for white women,

compared with 48 for black women, 73 for white 

men, and 111 for black men. Alaska Natives and

Native Hawaiian women have the highest lung 

cancer mortality rates among racial groups, 45 

and 44 per 100,000 respectively, compared with 

33 per 100,000 for black and white women.4

Among women and also men, the number of 

adenocarcinomas of the lung, a type of lung 

cancer more weakly associated with tobacco 

smoke than other histologic types, is rising.

In 1987, lung cancer first surpassed breast 

cancer as the leading cause of cancer deaths in 

women. More than 80 percent of lung cancer cases 

are directly attributable to cigarettes.5,6 Smoking 

is now the number one cancer killer of American

women, causing not only lung cancer but also 

cancers of the mouth, larynx, pancreas, bladder, 

kidney, cervix, and vulva. The human toll extends

beyond the smoker.7 It is estimated that 53,000 

people die annually from environmental tobacco

smoke, about half of them from exposure in the 

workplace. This issue is of particular concern to

women, since resistance to banning smoking in 

the workplace is particularly strong in restaurants 

and bars where approximately 80 percent of waitstaff and 53 percent of bartenders are women. A 

recent study reported that waiters and waitresses 

have a 50 to 90 percent higher risk of lung cancer 

than other workers after controlling for active smoking and socioeconomic status.7

Recent molecular and epidemiological evidence

shows significant gender differences and adds to 

the overwhelming data linking tobacco smoke with

cancer causation. Smokers whose parents had lung

cancer are twice as likely to develop lung cancer 

as the general population of smokers. In addition, 

men and women appear to respond differently to 

the carcinogens found in tobacco smoke. Compared

with men, women develop lung cancer after smoking

fewer cigarettes over a shorter time. Women may be

more sensitive than men to nicotine and have slower

metabolic clearance of nicotine. Another major gender

difference is the use of cigarettes among women and

girls for weight control.5

Smoking rates, which had previously been 

falling among adults, are now increasing. In 1994, 

48 million adults reported smoking, compared 

with 46 million in 1993. Twenty-eight percent 

of men and 23 percent of women smoke. Ninety 

percent of all smokers report that they began smoking during their teens. Regular smoking among high

school students, especially among white girls, is at 

an all-time high. American Indian youth have an 

even higher prevalence of cigarette use. Almost 

three-quarters (71 percent) of high school students

have tried cigarettes.8
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

The key to preventing lung cancer in U.S. 

women is to prevent initiation of smoking among 

adolescents and young adults. Optimizing prevention efforts targeted to children and adolescents is 

an urgent priority. Education about the health 

hazards of smoking beginning in early childhood 

and repeated into adolescence may be effective. 

Recognition of the role of peer pressure, self esteem

issues, and the urge to rebel against adult authority

must be incorporated into educational strategies. 

Antismoking messages must counteract the 

protobacco messages advanced by cigarette advertising and promotions. Tobacco industry advertising 

that connects smoking with slimness, social activity,

and popularity exerts a powerful impact on adolescent girls. Advertising campaigns aimed at young 

black and Latina women may have sparked recent

increased usage among these groups. Such advertising must be challenged in the public forum.

To be effective, antismoking messages must 

be tailored to a variety of ethnic, racial, and socioeconomic groups. Research to find the optimal form 

of oppositional advertising must consider the many

influences on young women who smoke, including

peer groups, school, work site, and the community

institutions in which women participate. 

Extensive research on smoking cessation will be

needed to help the many people who are now addicted

to tobacco or become addicted despite our efforts to

prevent smoking initiation. Clinical and research findings suggest that social support can play a significant

role in successful smoking cessation, particularly for

women. Additional research on the role of social 

support in smoking cessation is recommended.

Public policy initiatives may offer the greatest

promise of any strategy for reducing the number of

deaths and diseases due to smoking. Three critical 

public policy areas are the provision of smoke-free

environments, the prevention of youth access, and 

the outright banning of tobacco industry advertising

that targets youth and minorities.7 Legislation such 

as the recent Food and Drug Administration regulations designed to reduce youth smoking may be an

effective deterrent to reducing teen smoking. Litigation, such as medical cost reimbursement suits,10

also may help by providing market-driven disincentives,

that is, by raising the cost of purchasing cigarettes. 

Basic research to address genetic and metabolic risks for lung cancer and to support cessation

approaches for vulnerable populations remains 

important. About 70 percent of women who are 

currently smokers would like to quit. This figure 

is true across all ethnic groups (American Indians/

Alaska Natives – 70 percent, Asian Americans/Pacific 

Islanders – 65.3 percent, Blacks – 74.9 percent, 

Hispanics – 79.3 percent, Whites – 72.4 percent).9

Nicotine, a stimulant that can improve negative 

emotions such as depression may be particularly

important to women, who have higher rates of 

depression and, as a group, take more moodmodifying medications than do men. Research 

should examine the interactions among gender, 

mood modulation, and smoking patterns and their 

relevance to prevention and cessation interventions.

Percentage of High-School Students Who Were Smokers in the Previous Month, 1990-19949

AMERICAN INDIANS & ALASKA NATIVES ASIAN AMERICANS & PACIFIC ISLANDERS BLACKS HISPANICS WHITES

GIRLS 39.4 13.8 8.6 19.2 33.1

BOYS 41.4 20.6 11.6 28.5 33.4
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Development of reliable biomarkers and 

imaging technologies are urgently needed to improve

early detection of lung cancer. Identification of effective screening, followed by large-scale screening

approaches for people at risk could have a major

impact on death rates. The National Cancer Institute 

is supporting a randomized study of screening with

chest radiography as part of the Prostate, Lung, 

Colon, and Ovarian Cancer screening trial (PLCO).

This study will enroll 73,000 women and 73,000 

men. Special efforts are underway to ensure that 

Hispanic and black women and men have adequate

representation on this trial.

Identification of accurate biomarkers and 

surrogate endpoints may also simplify prevention 

studies. Preclinical studies to identify potential 

chemopreventive agents, followed by Phase I, II, 

and III chemopreventive trials, are also needed to 

prevent lung cancer. Diets rich in fruits and vegetables appear to lower the risk of lung cancer up to 

50 percent. Some evidence suggests that vitamins A, 

C, and E, and selenium, and other micronutrients 

may be beneficial in preventing lung cancer. Epidemiology studies of lung cancer may help identify

other potential chemopreventive agents and the 

etiologic agents for pulmonary adenocarcinomas 

in nonsmokers.

Advances in cancer treatment are urgently 

needed, because only 13 percent of individuals 

with lung cancer are alive 5 years after diagnosis.3

The timely completion of randomized clinical trials

evaluating surgery, chemotherapy, and radiation 

therapy are critical to progress in the treatment 

of lung cancer.

Breast Cancer

The incidence of breast cancer per 100,000

women rose dramatically between 1980 and 1987,

from 85 to 113, but it leveled in 1994 with a rate 

of 109 per 100,000.3 The American Cancer Society,

based on SEER data, estimated that, in 1997, 

180,200 women would be diagnosed with breast 

cancer, and 43,900 would die of the disease. White

women have the highest incidence of breast cancer, 

followed by Native Hawaiian women. For white

females the death rate has fallen slightly, from 28 per

100,000 women in 1985 to 26 per 100,000 in 1994.

For black women, however, the death rate has risen,

from 26 to 31 per 100,000 women, between 1973 

and 1994.4 Known risk factors include advancing 

age, family history, early age at onset of menarche, 

late age at onset of menopause, and first full-term 

pregnancy after age 30.

Since the Hunt Valley report, NIH has directed

substantial effort to breast cancer research, including

mammography. In 1994, breast cancer accounted for

20 percent of all NIH research expenditures for

women’s health issues.11 In addition, substantial 

funding for breast cancer research and screening 

has been provided by the Centers for Disease Control and Prevention and the Department of Defense.

This research and privately supported research may 

be beginning to make a difference. Breast cancer survivors now constitute the largest single group of cancer survivors. Many of them are young, with growing

families and productive lives. The many issues of cancer survivorship have particular resonance for them.

Advances in chemotherapy for breast cancer 

are noteworthy. Fifty-six new drugs for the treatment of breast cancer are in various stages of development, from Phase I through submitted new drug

applications.12 Several new drugs are based on innovative mechanisms. Thus, quality-of-life issues, including 

secondary malignancies and second primary malignancies, hormone administration to breast cancer 

survivors, and effects of early cancer on normal 

aging processes, will become increasingly important.

Important areas to study for breast cancer 

survivors include ways to optimize quality of life 

after treatment, to restore a positive body image 

and sexuality, and to maintain fertility after adjuvant

chemotherapy. Do estrogen replacement therapy, 

birth control pills, or even pregnancy after breast 

cancer treatment adversely affect outcome? What 

can be done to relieve the hot flashes, mood swings,
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

and night sweats of early menopause and to prevent

osteoporosis and heart disease associated with longterm estrogen depletion?

Questions surrounding the safety of long-term

HRT affect all midlife women, not just breast cancer

survivors. On one hand, women are urged to take

long-term hormone replacement for its benefits 

against cardiovascular disease, osteoporosis, and 

possibly even Alzheimer disease. On the other 

hand, a recent analysis of the large epidemiological

study, the Nurses’ Health Study, shows an increased

risk of breast cancer associated with long-term 

HRT.13 New medications with the benefits of HRT 

and fewer side effects are urgently needed. Pharmaceutical companies are developing “designer estrogen”

or “selective estrogen receptor modulators.” One, 

raloxifene, recently received FDA approval.12 Such

research needs to be encouraged. Epidemiological 

studies that determine what aspect of living in 

Western societies increases the rate of breast cancer in Asian women in the United States are also 

needed. If changes in diet are a factor, the evaluation 

of plant-based phytoestrogens, more prevalent in 

the Asian diet, could prove useful. 

Genetic loci responsible for some cases of 

familial breast and ovarian cancer have been identified. Tests for two of the most common genetic loci,

BRCA1 and BRCA2, are now commercially available.

Assuming a BRCA1 or BRCA2 mutation is found, 

however, the medical community is still profoundly

uncertain about the appropriate medical care for 

these women. How should these women be screened,

counseled, and followed? Under what conditions are

these tests most helpful and least harmful to women

and their families? Models for counseling need to be

developed, and legislation that prevents employment

and insurance discrimination is necessary. 

For women who carry mutations in BRCA1 or

BRCA2, until recently research data were not available

to evaluate prevention or early detection measures 

that might reduce morbidity and mortality.14 Some

women have opted for measures such as prophylactic

mastectomy. The Breast Cancer Prevention Trial 

evaluated the administration of a 5-year course of

tamoxifen to women at high risk for breast cancer. 

The important trial, which recruited 13,000 women,

was closed prematurely when a 45 percent reduction 

in breast cancer incidence associated with tamoxifen

was observed. Phase I, II, and III trials of new preventive strategies, which are particularly important for

women at high risk for breast cancer, should continue.

Issues of quality of life and adherence in prevention

studies also need scrutiny.

A better understanding of the etiology of 

breast cancer is critical to developing new prevention, diagnosis, and treatment strategies. Research 

priorities include the basic biology of the breast, 

mechanisms of carcinogenesis, and genetic, hormonal, and environmental factors. As the development of breast cancer is better understood, detection 

of neoplastic lesions at greatest risk for progression 

to cancer may become more accurate, and the significance and management of these precancerous lesions

better understood. New imaging modalities may 

help to identify persons at high risk for developing

breast cancer and identify smaller cancers before

metastasis occurs.

Meanwhile, data continue to support the use 

of routine screening mammography for detecting 

breast cancer at an early stage. Between 1983 and

1994, the detection of in situ cancer rose by 107 

percent in white women under age 50, 166 percent 

in black women under age 50, 220 percent in white

women age 50 years or older, and 232 percent in 

black women age 50 or older. Studies of minimally

invasive and alternative conservative therapies are

needed to avoid overtreatment of precancerous 

and in situ lesions.

Although survival rates have improved overall,

fewer black women diagnosed with breast cancer 

survive than white women. Between 1986 and 1993,

5-year survival rates were 71 percent for black women

but 86 percent for white women. A recent study 

suggests that 75 percent of the difference in survival
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between black and white women may be explained 

by late diagnosis, tumor characteristics, concomitant

illness, obesity, and social and demographic factors.15

The most recent NCI, ACS, and ACR screening

guidelines recommend that all women aged 40 years 

or older obtain mammograms every 1 to 2 years. 

Data from the 1994 Health Interview Survey show 

that 56 percent of black and white women aged 50

years or older had a mammogram during the previous 2 years, as well as 53 percent of American 

Indians, 50 percent of Latinas, and 46 percent of

Asian-Pacific Islanders. Poverty and the lack of 

insurance are the chief factors associated with low 

utilization. Disabled women also have low rates 

of breast self-examination and mammography.

Improved access to screening and education of 

patients and health care providers to increase 

utilization rates for all ages and all racial and ethnic

groups is a major priority for lowering breast cancer

rates. Psychosocial and behavioral research is needed 

to identify culturally acceptable interventions to

increase use of screening, diagnosis, treatment, 

clinical trials, and supportive care among medically

underserved women.

Treatment issues remain important. Development of refined molecular diagnostics may identify

women with breast cancer who may be safely treated

with surgery alone, and who would benefit from 

adjuvant chemotherapy or radiotherapy. The role 

of sentinel node assessment needs to be evaluated. 

The effectiveness of tamoxifen in reducing the risk 

of recurrent or contralateral breast cancer supports 

further investigation of endocrine therapy for both 

prevention and treatment. The efficacy of high-dose

chemotherapy coupled with hematologic support 

(stem cell transplant) is currently under evaluation 

in randomized, controlled clinical trials. New treatment approaches using monoclonal antibodies, 

tumor vaccines, and angiogenesis inhibitors are 

in Phase I and II studies. New methodology is 

required to assess the roles of these agents. Longterm strategies such as weight control, physical 

activity, and antioxidants should be considered 

to prevent first or second primary cancers or as 

adjuvant therapy to prevent cancer recurrence. 

Colorectal Cancer

In 1997, an estimated 65,900 women were 

diagnosed with cancer of the colon or rectum, and

24,300 died of the disease.1 The highest incidence is

among Alaska Native women (52 per 100,000 women),

followed by black women (46 per 100,000), Japanese

women (29 per 100,000), and white women (27 per

100,000).4 Although screening tests for colorectal 

cancer are readily available, recent reports show that

many women are not being screened.16 Prevention

efforts must include new strategies to educate both

women and their physicians about the benefits of

screening women for colon cancer.

Acceptable screening strategies include fecal 

occult blood testing, sigmoidoscopy, colonoscopy, 

and barium enema. For those at normal risk, screening should begin at age 50. Individuals at increased

risk for colon cancer should begin screening earlier.

Further studies are needed to determine the optimal

combination of these tests and how best to integrate

them into standard clinical practice.16

Since the Hunt Valley conference, knowledge

about factors that increase and decrease the risk of

colon cancer has expanded. Familial adenomatous

polyposis coli and hereditary nonpolyposis colon 

cancer (Lynch II) are the most common familial 

syndromes identified with colon cancer. Multiple

genetic loci for these syndromes have now been 

identified. Other factors have been associated with 

a decrease in colon cancer risk, including HRT, 

nonsteroidal anti-inflammatory agents, exercise, and 

a low-calorie, low-fat, high-fiber diet. Prospective 

randomized prevention trials are evaluating these 

and other agents such as selenium and calcium. 

Since the Hunt Valley meeting, several new 

drugs have shown activity against colon cancer. 

Many treatment-related questions remain unanswered,

however. After primary surgery for stage III colon 

cancer, the combination of 5FU and leucovorin or 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

levamisole is effective in reducing recurrences and

death from colon cancer. Women appear to be more

sensitive to 5FU toxicity than men. The mechanism

leading to this toxicity needs to be identified and 

preventive strategies developed. Such strategies might

include new chemotherapeutic agents and combinations to improve cure rates and reduce toxicity from

adjuvant therapy.

A current intergroup Phase III trial is evaluating

laparoscopic surgery in early colon cancer. Neoadjuvant chemoradiation has been effective in preserving

normal rectal sphincter function in patients with rectal

cancer. Improvements in chemotherapy and radiation

therapy may improve long-term survival in patients

with locally advanced rectal cancer. Patients with 

liver metastases can have long survival. Ongoing 

trials evaluating whether chemotherapy can convert

nonresectable to resectable liver disease and prolong

survival and whether chemotherapy after surgical

resection of metastases is effective in prolonging 

survival should be continued.

Ovarian Cancer

Ovarian cancer accounts for about 4 percent 

of all cancers in women and 6.7 percent of all cancer

deaths. In 1997, about 26,800 new cases of ovarian

cancer were diagnosed in the United States, and

14,200 women died of ovarian cancer.3 According 

to the Society of Gynecologic Oncologists, a relative

survival rate of 90 percent can be achieved if ovarian

cancer is diagnosed early. Unfortunately, in 70 percent of the women, ovarian cancer is detected at 

an advanced stage, which has an 80 percent fatality

rate.17 Identification of effective screening procedures is critical if survival is to be improved. 

No screening test or combination of tests 

reliably diagnoses early ovarian cancer. Screening 

tests currently in use include serum CA-125, gynecologic examinations, and transvaginal ultrasound. 

At present, the sensitivity, specificity, and positive 

predictive value of these screening tests are inadequate to warrant their use in the general population,

even when used together. Timely completion of 

large-scale Phase III screening trials under way in 

the United States (PLCO) and Europe will help evaluate the effectiveness of serum CA-125 and ultrasound.

Other strategies to screen for ovarian cancer need to 

be developed and evaluated.

Known risk factors for ovarian cancer include

abnormal BRCA1 and BRCA2; advancing age; nulliparity; Northern American or Northern European

descent; a personal history of endometrial, colon, or

breast cancer; and a family history of ovarian cancer.

Protective factors include pregnancy, lactation, and 

the use of oral contraceptives. The role, if any, of 

infertility treatment, is poorly understood. A better

understanding of the epidemiology, genetics, and 

biology of ovarian cancer is critical if advancements 

in treatment and prevention are to occur.

Prevention trials are problematic because the 

etiology of ovarian cancer is not well understood.

Nonetheless, population-based data on the protective effect of birth control pills and preliminary 

data on retinoids suggest that prevention trials 

can be designed for high-risk individuals. Some

women with BRCA1 or BRCA2 mutations are 

opting for prophylactic oophorectomy. Unfortunately, data on any effectiveness of this extremely 

invasive preventive method are few. Collection 

of such information represents an especially 

critical research need.

A 1997 study showed that only 14 percent of

women with early-stage ovarian cancer received the

surgical staging and treatment recommended by an

NIH Consensus Panel.18 In 40 percent of the cases, 

no pathologic grade was assigned to the cancers

removed. New approaches to physician and consumer education, including psychosocial and 

behavioral research, are needed. Women should 

be informed of the need to have doctors with the

appropriate expertise in gynecologic cancer surgery 

and pathology available at the time of surgery.

The clinical significance and relation of invasive

carcinoma to “borderline” ovarian tumors are poorly

understood. Some of these lesions may be overdiag-
“The tragic and commanding fact about 

ovarian cancer is that more than 50 percent of the 

women who have it die within 5 years of diagnosis.”

Ann Kolker

Ovarian Cancer 

National Alliance: 

Ovar’coming Together

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VOLUME 2

nosed or overtreated. Research on their biology and

clinical management is encouraged. 

Intraperitoneal therapy, immunotherapy, 

radiotherapy, and high-dose chemotherapy with 

hematologic support are current research strategies. 

In patients with advanced disease, optimal debulking surgery followed by appropriate paclitaxel and 

platinum-based chemotherapy prolongs survival. 

The current Phase III trial of high-dose chemotherapy versus standard consolidation therapy 

should be promoted. Approaches to ovarian cancer 

are needed, including new chemotherapeutic agents

more effective for women with recurrent or persistent ovarian cancer, with survival and quality of 

life as major ends. 

Malignant germ cell tumors of the ovary, 

although rare in the general population, constitute most ovarian cancers in young women under 

20 years of age. Recent therapeutic advances, 

which produce a high cure rate and can preserve 

fertility, should be extended.

Cervical Cancer

In 1997, the estimated number of American

women with a new diagnosis of cervical cancer was

14,500; some 8,000 women were estimated to have

died of the disease.3 Since 1973, the incidence of 

cervical cancer has fallen 40 percent among white

women and 60 percent among black women, and 

mortality has fallen 44 percent for white women 

and 52 percent for black women.3 Worldwide, 

cervical cancer is second only to breast cancer in 

incidence and mortality from cancer in women. 

More than 471,000 new cases are diagnosed each 

year, predominantly among the economically disadvantaged, in both developing and industrialized

nations. In the United States, the highest incidence 

of cervical cancer is found among Vietnamese women

(43 per 100,000), followed by Alaska Native women

(16 per 100,000), Korean women (15 per 100,000)

and black women (12 per 100,000). The mortality 

rate for black women (6.3 per 100,000) is more 

than twice that of white women (2.5 per 100,000).4

Invasive cervical cancers and precursor lesions 

are firmly associated with specific strains of sexually

transmitted human papilloma virus (HPV). The HPV

genes E6 and E7 are integrated into the host genome

and inactivate p53 and Rb gene products. The prevalence of infection decreases with increasing age, 

suggesting that most infections resolve over time

through host immune responses.

Several cofactors, including cigarette smoking, 

may contribute to the development of cervical cancer. Immunosuppressed women, whether due to 

corticosteroids or HIV infection, are at increased 

risk for precursor cervical lesions and cervical cancer. The role of immune response in cervical cancer,

including growth factors, cytokines, and humoral 

and cellular immunity, is still under study. Other 

factors under study include the use of oral contraceptives, number of live births, age at first intercourse, and coinfection with other sexually 

transmitted diseases.

The primary prevention of HPV infection is a

research strategy to reduce the incidence of cervical

cancer. Public health efforts to prevent HPV infection

must focus educational efforts toward adolescents 

to encourage the delayed onset of sexual intercourse.

Women of all ages and their health care providers 

must understand the strong causal link between the

acquisition of HPV as a sexually transmitted disease

and the development of cervical cancer. Development

of effective vaginal microbiocides and a prophylactic
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

HPV vaccine are ultimately needed. Secondary 

preventive efforts must focus on developing effective

antiviral agents to treat HPV, or to prevent transformation by E6/E7, and on therapeutic vaccines to 

prevent HPV progression.

Squamous cell cervical cancer is an ideal 

disease for screening because the typically long 

preclinical phase provides the opportunity for 

early detection. Use of Pap smears reduces morbidity and mortality from cervical cancer. However,

optimal management of patients with certain precursor lesions, atypical cells of undetermined 

significance, and low-grade squamous intraepithelial lesions, is not established. A large NCIsponsored clinical trial is currently evaluating 

the different ways to manage these patients. 

Research to improve current screening technology also should be encouraged. Liquid-based 

specimen collection methods and computer-aided

screening of Pap smears, recently approved by the

Food and Drug Administration, need further 

evaluation in routine primary screening and 

in subsequent screening.

Despite the recognized benefits of Pap smear

screening, many American women have not been

screened or are not being screened at regular intervals. One-half of the women with newly diagnosed

invasive cervical carcinoma have never had a Pap

smear, and another 10 percent have not had a Pap

smear in the past 5 years. Inadequately screened 

populations include older women, the uninsured, 

the disabled, ethnic minorities (especially Latinas, 

certain Asian subgroups, and elderly black women),

and poor women, particularly those in rural areas.

Data from the 1992 Health Interview Survey 

show that one-half of all women 60 years and older

have not had a Pap smear in the past 3 years.19

Older women are screened less frequently, although

they have as many recent physician visits as younger

women, showing the need to educate older women 

and their health care providers about the importance 

of Pap smear screening. Reasons for nonparticipation 

in screening should be identified and appropriate 

interventions taken.

New developments in therapy are needed. 

The development of more accurate imaging studies

would improve the definition of the extent of disease 

at presentation and refine radiation therapy plans.

Development in molecular diagnostic markers may

help identify those patients with disease confined 

to the cervix who might benefit from adjuvant 

therapy after hysterectomy. The optimal adjuvant 

regimen for patients with disease confined to the

pelvis, whether radiation, chemotherapy, or both, 

has not yet been defined. Clinical trials are also 

needed to define the role of prophylactic or 

therapeutic para-aortic node radiation.

Optimal management of HIV-positive women 

with precursor lesions and cervical cancer remains 

to be determined. Defining any impact of p53 status

and HPV subtypes may allow customizing of treatment strategies. Dose-response relationship, time/

dose relationship, improvements in technical instrumentation, and optimization of brachytherapy techniques should be studied further. Predictive assays 

for tumor and normal tissue radiation sensitivity 

might allow individualization of radiation prescriptives. Strategies to reverse anemia and tissue 

hypoxia could improve the radiation responsiveness of the tumor. 

Adenocarcinoma and other nonsquamous 

cervical carcinomas may be increasing in frequency, 

but the biology of their precursor lesions is poorly

understood. Studies are needed to define the epidemiology, biology, natural history, and treatment 

of nonsquamous cancers and their precursors. 

Clinical trials are needed to define the benefit 

of neoadjuvant chemotherapy. 

Uterine Cancer

Based on SEER data, 34,900 women were diagnosed with cancer of the uterus in 1997, and 6,000

women died of the disease.1 The highest incidence

rates for uterine cancer are among Native Hawaiian 
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VOLUME 2

and white women (24 and 22 per 100,000, respectively). Most uterine cancers arise in the endometrial

lining of the uterus (endometrial adenocarcinoma); 

the remainder form in the muscle wall of the uterus

(uterine sarcomas and carcinosarcomas). Eighty percent of women with endometrial cancer develop 

abnormal vaginal bleeding, prompting early 

evaluation and treatment, usually hysterectomy.

Mortality from endometrial cancer is highest for

Native Hawaiian women (9 per 100,000), followed 

by black women (6 per 100,000) and white women 

(3 per 100,000).3 Although the time from the onset 

of symptoms to treatment appears similar for blacks

and whites, the incidence of carcinomas associated

with normal estrogen levels is higher among black

women. These tumors are associated with a higher

stage at diagnosis, a greater propensity to metastasis,

and worse survival.

Risk factors for endometrial adenocarcinoma

include anovulation, obesity, diabetes, Lynch II 

syndrome (hereditary nonpolyposis colon cancer), 

and estrogen unopposed by progesterone. Elevated

estrogen levels may be endogenous (associated with

obesity or certain ovarian tumors) or exogenous 

(from estrogen replacement therapy or tamoxifen). 

Protective factors include pregnancy, lactation, 

oral contraceptives, and progestins. Atypical endometrial hyperplasia is a known precursor lesion. 

The etiology of other histologic subtypes of 

endometrial cancer is unclear.

Research on the basic biology of endometrial 

cancers, uterine sarcomas, and carcinosarcomas 

is critical to develop more effective prevention and

treatment programs. Clinical trials aimed at preventing endometrial cancer, particularly for obese or 

anovulatory women or women on tamoxifen, should

be encouraged. The role of ultrasound in screening 

for endometrial cancer deserves further evaluation.

The association of many cases of endometrial 

cancer with elevated estrogen levels suggests that 

progestins or “designer estrogens” might be effective 

for treatment of atypical endometrial hyperplasia, 

thus sparing some women a hysterectomy. Ongoing

clinical trials, evaluating the role of laparoscopic

surgery, adjuvant radiotherapy, and chemotherapy, 

and also systemic chemotherapy for patients with

metastatic disease, should be expanded.

RESEARCH 

RECOMMENDATIONS

Public Health Research Efforts

• Expand clinical trials evaluating single- and 

multimodality methods for smoking prevention

and cessation.

• Expand trials evaluating the effects of exercise 

and weight control on cancer risk.

• Identify behavioral issues affecting adherence to

recommended guidelines for cancer prevention,

screening, and treatment.

• Evaluate the cumulative effects of environmental,

exogenous, and endogenous estrogens (including

DES, HRT, and oral contraceptives) on cancer 

risk and support continued epidemiologic 

research on previously identified cohorts.

• Design, evaluate, and implement culturally 

competent interventions to overcome barriers 

to women’s participation in cancer prevention,

detection, treatment, and outcomes research.

Include older women, minorities, and rural

women, traditionally underrepresented on 

cancer treatment trials, as a high priority. 

• Study how managed care has transformed 

the delivery and economics of health care 

and hampered access of cancer patients to 

optimal treatment, research studies, and 

cancer centers. Barriers to participation in 

cancer screening and prevention research 

programs and barriers that limit access to 

appropriate specialists, clinical trials, and 

treatment are unethical and shortsighted. 

All Americans must have access to optimal 

cancer treatment, and representation of 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

women and minorities in clinical trials 

must be a high priority. 

Biology and Genetics

• Consider how consumers and all concerned 

scientific disciplines must work together to 

facilitate the appropriate use of tissues for 

research. The ethical and legal implications 

of research on tissues stored in repositories 

must be carefully assessed, particularly issues

involving consent and confidentiality.

• Define the molecular, genetic, cellular, and 

physiologic mechanisms associated with 

cancer initiation, development, and spread. 

The biology of premalignant lesions remains

important. Identification of better biomarkers,

including susceptibility to carcinogens, 

should help to further cancer prevention, 

early detection, and individualization of 

cancer treatment.

• Define the cancer risk associated with identified

genetic mutations. The social, ethical, legal, and

economic effects of the new commercially available genetic tests should be carefully studied, 

and appropriate counseling models, linked to

genetic testing, should be developed.

• Develop medications with fewer side effects 

(efforts must be by the National Cancer Institute,

the pharmaceutical industry, and the Food and

Drug Administration).

Interventions

• Ensure adequate funding, efficient management, and timely completion of Phase I and 

II and randomized trials to examine new 

prevention and treatment strategies.

Prevention

• Identify effective screening tests for all cancers.

• Continue research on the role of steroid 

hormones in cancer prevention and causation 

and translate that knowledge into effective

approaches to lower cancer risk.

• Design prevention and screening strategies 

appropriate to individuals at increased genetic 

risk for cancer.

• Develop chemoprevention strategies and 

vaccines against cancer.

• Enhance research efforts to communicate 

cancer risks and encourage health-promoting

behavior in targeted populations. 

• Give high priority to communicating the 

risks of smoking, preventing the initiation 

of smoking by children, and smoking 

cessation in children and adults already 

addicted as our only effective strategy 

against lung cancer. 

• Communicate the risks of early sexual 

activity and of multiple sexual partners 

(or of sexual partners who have had 

multiple partners), and encourage appropriate behavioral changes to decrease the 

transmission of HPV and HIV to decrease 

the risk of cervical cancer and HIV-associated 

lymphoma and Kaposi’s sarcoma.

Diagnostics

• Continue to develop and validate diagnostic 

and screening tests. New imaging algorithms 

that combine functional, metabolic, and 

anatomic imaging should be evaluated.
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VOLUME 2

• Define optimal tests for the early detection 

of cancers and precancerous lesions. Tests 

should be inexpensive, highly sensitive and 

specific, and acceptable and available to 

women of all socioeconomic strata.

Therapy

• Ensure appropriate access to and adequate 

funding for randomized clinical trials to 

evaluate new methods and therapies.

• Review existing NIH mechanisms for large, 

multicenter clinical trials to increase efficiency 

and more rapid completion.

Outcomes

• Expand psychosocial, sociocultural, and 

behavioral research of the differing perceptions 

of risks and benefits between consumers and

providers to design better prevention, screening, treatment, and outcomes interventions.

• Expand research on issues affecting cancer 

survivors, including quality of life, the most 

effective followup care, and reproduction and 

fertility outcomes after treatment. Studies of 

the long-term effects of chemotherapy and 

radiation are also important.

• Continue studies of gender differences in 

response to pain and analgesia.

Overarching Issues

• Consider the 41 million U.S. citizens without

health insurance and the many more who are 

inadequately insured. Uninsured individuals 

often do not have access to prevention or 

screening programs. Precancerous lesions 

and early cancers may go undiagnosed and 

untreated. When patients seek medical care, 

treatment may no longer be effective. The 

medical research community must work 

with policymakers to ensure that adequate 

access to health care is available to all U.S. 

citizens and that health promotion becomes 

part of the activities of daily living.

• Continue research on enhancing adherence 

to health recommendations.

• Facilitate communication among investigators, 

clinicians, patients, and the public. Clinicians 

frequently define observations needing laboratory

explanations, while promising laboratory developments need timely clinical evaluation.

• Facilitate evidence-based medicine, disseminate

and integrate research results into practice patterns.

• Teach health care providers skills in communicating risks and in encouraging health-promoting

behavior to their patients and the public.

• Develop, evaluate, and carry out educational 

and intervention programs that are sensitive 

to an individual’s cultural and socioeconomic 

background.

• Collaborate with colleagues from other disciplines

to expand and strengthen research into the benefits

and risks of steroid hormones in women’s health.

References

1 Parker SL, Tong T, Bolton S, Wingo PA. Cancer statistics,

1997. CA Cancer J Clinicians 1997 (Jan/Feb);47(1):5-28.

2 Williams L. PEPI: reducing risk factors for heart disease.

NIH News & Features (special issue) Fall 1997:14-15.

3 Ries LAG, Kosary CL, Hankey BF, et al. (eds). SEER 

Cancer Statistics Review, 1973-1994. NIH Pub. No. 

97-2789. Bethesda, Md: National Cancer Institute, 1997. 

4 Miller BA, Kolonel LN, Bernstein L, et al. (eds). Racial/

ethnic patterns of cancer in the United States 1988-1992.

NIH Pub. No. 96-4104. Bethesda, Md: National Cancer

Institute, 1996.

5 Erickson M. Smoking and women: a major “disconnect.”

JAMWA 1996 Jan/Apr;51(1,2):7, 18.
72

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

6 Blumenthal SJ. Smoking v women’s health: the challenge

ahead. JAMWA 1996 Jan/Apr;51(1,2):8.

7 Scheg KE. Public policy: Effective treatment for tobacco

disease. JAMWA 1996 Jan/Apr;51(1,2):52-6, 69.

8 Kann L, Warren C, Harris W, Collins J, Williams B, 

Ross J, Kolbe L. Youth risk behavior surveillance: 

United States, 1995. MMWR Morb Mortal Wkly

Rep 1996;45(SS-4).

9 US Department of Health and Human Services. Tobacco

use among U.S. racial/ethnic minority groups — African

Americans, American Indians and Alaska natives, Asian

Americans and Pacific Islanders, and Hispanics: a report 

of the Surgeon General. Atlanta, Georgia, US Department

of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease

and Prevention and Health Promotion, Office on Smoking

and Health, 1998.

10 Keldner GE Jr, Daynard RA. Tobacco litigation as a 

public health and cancer control strategy. JAMWA 1996

Jan/Apr;51(1, 2):57-62. 

11 National Institutes of Health. NIH Support for Research 

on Women’s Health Issues, Fiscal Years 1993-1994. NIH

Pub. No. 98-3983. Bethesda, Md.: 1998; p. 30, 34.

12 New medicines in development for women. Washington,

D.C.: Pharmaceutical Research Manufacturers Association,

October 1997. 31 pp.

13 Grodstein F, Stampfer MJ, Colditz GA, Willett WC, 

Manson JE, Joffe M, Rosner B, Fuchs C, Hankinsen SE,

Hunter DJ, Hennekens CH, Speizer FE. Post menopausal

hormone therapy and mortality. N Engl J Med 1997;

336(25):1769-75.

14 Biesecker BB, Brody LC. Genetic susceptibility testing 

for breast and ovarian cancer: A progress report. 

JAMWA 1997 Winter;52(1):22-7.

15 Eley JW, Edwards B. Racial differences in survival from

breast cancer. JAMA 1994;272:947-54.

16 Winawer SJ, Fletcher RH, Miller L, et al. Colorectal 

screening: clinical guidelines and rationale. Gastroenterology 1997;112:594-642. 

17 Brooks MD. Summary of Testimony, Beyond Hunt 

Valley: Research on Women’s Health for the 21st Century,

November 17, 1997.

18 Munoz KA, Harlan LC, Trimble EL. Patterns of care for

women with ovarian cancer in the United States. J Clin

Oncol 1997;15:3408-15.

19 Brown CL. Screening patterns for cervical cancer: how 

best to reach the unscreened population. Monogr Natl 

Cancer Inst 1996;21:7-11.
CARDIOVASCULAR 

DISEASES

BACKGROUND 1-3

The 1991 Hunt Valley conference, “Opportunities for Research on Women’s Health,”acknowledged cardiovascular disease as a 

critical issue because of its prevalence, its importance

as the leading cause of death among women, and its

disproportionate impact on some racial and ethnic

groups. The conference also highlighted differences

between women and men with respect to research 

in cardiovascular disease and to the diagnosis, 

treatment, and management of symptomatic 

and asymptomatic disease. 

During 1996 and 1997, three regional meetings

sponsored by the Office of Research on Women’s

Health (ORWH) examined progress in research on 

cardiovascular diseases in women and articulated 

issues that needed further examination. The conclusion was that many important questions remain

unanswered and that there is significant need for 

further research on the molecular, cellular, physiologic, and behavioral levels.

Cardiovascular disease is the number one 

killer in the United States. It kills more than 960,000

Americans each year, about 1 person every 33 seconds.

The disease also is a major cause of disability. About

13.5 million Americans, including 6.6 million women

and men under the age of 60, now live with the consequences of heart attack. Approximately 4 million

Americans suffer from the consequences of stroke, 

the main cause of permanent disability in the 

United States. More than 900,000 of these stroke

patients are under the age of 60.

Costs of cardiovascular disease are measured 

not only in terms of lives lost or affected but also 

in the dollars needed to diagnose, treat, and manage

these diseases. More than one in four Americans has

some form of cardiovascular disease, resulting in an

estimated cost of $151 billion in 1996. These costs 

will continue to grow because the disease is being

treated with expensive technology, not prevented.

Moreover, even more cardiovascular disability will

occur in the future because many people who have

effective treatment for coronary artery disease and 

atherosclerosis between the ages of 40 and 60 may

develop further cardiovascular disease later in life

unless effective prevention methods are undertaken.

Cardiovascular disease is a well-known killer 

of men in the United States. What is less known 

is that heart disease has been the number one killer 

of women for nearly a century. Cardiovascular disease

accounts for about 45 percent of all deaths among

American women. Of the more than 960,500 deaths

from heart attack each year, more than 52 percent

occur in women. Cardiovascular disease kills almost

twice as many American women as all cancers combined and more than 11 times as many women as 

does breast cancer. A postmenopausal woman is 

10 times as likely to die from coronary artery 

disease as from breast cancer.

Cochairs

David Robinson, Ph.D.

National Heart, Lung, and Blood Institute

National Institutes of Health 

Judith LaRosa, Ph.D., R.N., F.A.A.N.

Tulane University School of Public Health 

and Tropical Medicine

Nanette K. Wenger, M.D., F.A.C.C., M.A.C.P.

Emory University School of Medicine

Rapporteur: Anne Brown Rodgers

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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Women develop heart disease later in life than 

do men, but, at any age, heart attack is more deadly 

for women. Older women who have suffered heart

attacks are twice as likely as men to die from them

within a few weeks. About 44 percent of women 

who have heart attacks die within a year, whereas 

only about 27 percent of men die within a year. 

Among women who die suddenly of coronary heart

disease, 64 percent have no previous symptoms, 

compared with 48 percent of men. For black women,

the rates are even more ominous. The heart attack

death rate for black women between the ages of 

35 and 74 is about twice that of white women 

and three times that of women of other races.

Other cardiovascular diseases are also prevalent 

in women. For example, stroke, America’s number

three killer, killed about 158,000 people in 1995. 

Of these, 61 percent were women. Stroke kills 

twice as many women as does breast cancer. Less

prevalent cardiovascular diseases include rheumatic

heart disease, a disease that permanently damages 

the heart and its valves. Again, mortality from this 

disease is higher for women (69.9 percent of all 

deaths) than for men.

Dramatic progress has been achieved against 

heart disease in recent decades. Declines in overall

death rates from heart disease have been spectacular, 

in both men and women. The rate in men is now 

about the same as at the turn of the century, and 

the rate in women is actually 37 percent lower than 

it was in 1900. Declines in younger age groups 

have been particularly significant.

However, the prevalence of heart attack and 

other cardiovascular diseases remains disturbingly

high. Risk factors for heart disease in women and 

men have been known for years, but until recently,

heart attack, stroke, and other cardiovascular diseases

in women have not been recognized as a serious problem, particularly by women themselves. Significant

gaps still exist in our knowledge of the normal development of the cardiovascular system in women; 

diagnosis, treatment, and management of cardiovascular disease; participation and retention of 

women in clinical research; and behavioral and 

lifestyle issues that are important in the development

and prevention of cardiovascular disease. Analysis of

these gaps provides potential fruitful avenues for

research, many of which are described below.

TABLE 1. Five Leading Causes of Death for Population Groups in the United States; 1995 Mortality, Final Data

WHITES BLACKS HISPANICS ASIAN/PACIFIC ISLANDERS

Female Male Female Male Female Male Female Male

Total cardiovascular disease 1111

Diseases of the heart and stroke 1 1 1 1

Cancer 222222 2 2

Accidents 5 3 5 4* 4 3 3 3

HIV/AIDS 4 3 4

Chronic obstructive pulmonary disease 3 4 5

Pneumonia/influenza 4 5 5 4 4

Homicide 4* 5

Diabetes mellitus 3 3 5

* Tied ranking.

Source: National Center for Health Statistics: Health, United States, 1995, and the American Heart Association
“As obesity is becoming more prevalent, 

particularly among women, and affects a number 

of risk factors as well as risk for coronary heart 

disease itself, further research into its causes and

treatment are needed.”

Marian C. Limacher, M.D.

American College 

of Cardiology

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SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

Participants in the 1991 Hunt Valley conference

made 14 recommendations dealing with cardiovascular function and disease. These focused primarily 

on psychosocial and clinical issues. In examining 

these recommendations and other issues relating to 

cardiovascular disease, participants at the 1996 and

1997 Beyond Hunt Valley meetings recognized that 

significant progress has been made since establishment of ORWH. ORWH has made important contributions to the following areas:

• Basic and applied biomedical research funding

opportunities in women’s health, especially 

those in cardiovascular research.

• Types of research (health services, cost 

effectiveness, population-based, community) 

pertaining to women’s health.

• Participation of women, especially diverse 

groups of women, in clinical studies.

• Cardiovascular treatment regimens in 

women’s health.

• Participation and advancement of women 

in science.

• Number and outreach capacity of professional 

societies related to women’s health.

• Number of men active in women’s 

health research.

GAPS IN KNOWLEDGE

The Cardiovascular Diseases Working Group 

identified gaps in five key areas.

Developmental Biology of the Vascular System 

and Role of Fetal Environment in Programming 

Lifelong Cardiovascular Function

Significant gaps remain in our knowledge of 

the normal development and functioning of the 

cardiovascular system in females and of the numerous

physiologic, environmental, and behavioral factors 

that influence the development of cardiovascular 

disease in women. For example, we need to know

more about basic mechanisms of development of 

the cardiovascular system and how its functioning

changes through adulthood into very old age. Other

issues where information is needed include:

• Mitral and other valve function in normal 

populations over different ages.

TABLE 2. The Leading Causes of Death in Women, U.S., 1995

CAUSE OF DEATH NUMBER PERCENT

Heart Disease 374,849 32.9

Cancer 256,844 22.5

Stroke 96,428 8.5

COPD 48,961 4.3

Pneumonia/Influenza 45,136 4.0

Diabetes 33,130 2.0

Accidents 31,919 2.8

Alzheimer 13,607 1.2

Nephritis 12,287 1.1

Septicemia 11,974 1.1

All Other 214,038 18.8

Source: Vital Statistics of the U.S., National Center for Health Statistics
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• Cardiovascular-related diseases during pregnancy.

Pregnancy is a unique time and setting in which

several important cardiovascular disease risk 

factors emerge, such as gestational diabetes, 

hypertension, and toxemia. Toxemia is an old 

disease, but despite some emerging knowledge, 

little is known about its etiology, prevention, 

and management. A greater understanding of 

the development of toxemia may shed light 

on the pathogenesis of cardiovascular disease 

more broadly.

• Gender differences in effects of medications 

traditionally prescribed to treat cardiovascular 

disease.

• Presymptomatic disease, including ways in 

which detection in asymptomatic women can 

be improved. Events that trigger the conversion 

of an asymptomatic, atherosclerotic lesion to 

symptomatic disease also need to be understood more fully.

Interest is growing in the role of the fetal 

environment in programming lifelong cardiovascular

function. Suboptimal intrauterine conditions may 

cause a fetus to redistribute its resources to preserve

the nutrient and oxygen supply for the brain. This 

may result in deprivations to the gut, liver, and 

carcass. If these processes continue, the baby will 

be born with a small liver and altered vasculature 

in many vital organs. Ongoing animal studies suggest that these changes predispose to high blood 

pressure and diabetes in later life. 

In keeping with these animal studies, epidemiologic investigations in several countries now indicate

that decreased birth weight and altered placental

growth are associated with a higher incidence of 

cardiovascular disease in later life. A clearer understanding of this fetal “programming” is essential 

to preventing the adverse consequences of a suboptimal period of intrauterine development.

Molecular and Physiologic Mechanisms of 

Hormone Action in the Cardiovascular System

Given the important protective role that estrogen

and other hormones appear to play in cardiovascular

disease,4 the rapidly developing molecular and cellular

biology research techniques in this area, and the public

debate over hormone replacement therapy, research 

in the molecular and physiologic mechanisms of 

hormone action in the cardiovascular system is a 

high priority.5-7 We know there are two types 

of estrogen receptors and that estrogen can cause

immediate (nongenomic) and long-term (genomic)

effects on the vasculature.8 However, there are 

gaps in our knowledge with respect to:

• The distribution of alpha and beta receptors

throughout the vasculature, and how this 

distribution changes with age and disease.

• The cellular events triggered by activation 

of the two receptors.

• The ways in which manipulation (stimulation 

or inhibition) of the receptors affects progression of cardiovascular disease.

• The ways in which the relative expression 

of receptors might be used to identify women 

at risk for cardiovascular disease.

Cardiovascular Implications of Diabetes and Obesity

Diabetes and obesity and their relationship 

to the development of cardiovascular diseases pose

many unanswered questions. Insulin-dependent 

diabetes mellitus is an important cause of premature

cardiovascular disease among young women and 

Source: Vital Statistics of the U.S., National Center for Health Statistics

TABLE 3. NHLBI Major CVD Clinical Trials – History

First Trial in 1965

59 Trials from 1965 to 1997

41 included both men and women

4 included men only

14 included women only
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VOLUME 2

men under 45 years of age. Cardiovascular disease 

is especially high among premenopausal women 

who have insulin-dependent diabetes mellitus 

and smoke cigarettes. 

High body mass index, weight gain, and 

obesity are associated with increased blood pressure, elevated serum lipid levels, and development 

of type II diabetes, all of which are major risk factors for cardiovascular disease. Obesity is also an 

independent risk factor for cardiovascular disease. 

It affects outcomes following a cardiovascular 

disease event, as well as treatments for cardiovascular disease. Despite the attention directed 

to obesity, its causes and treatments are poorly 

understood. Gender differences in obesity also 

are not well understood. As a health problem, 

obesity continues unabated and its prevalence 

is increasing. Research is needed to more fully 

understand this condition as well as its relationship to cardiovascular disease.

Prevention, Detection, and Management of 

Cardiovascular Disease in High-Risk Populations

An important gap in current knowledge 

involves prevention, detection, and management 

of cardiovascular disease in high-risk populations

across socioeconomic levels. These populations, who

disproportionately experience the effects of cardiovascular disease, include the elderly, women with 

disabilities, and racial and ethnic minority groups, 

such as blacks, Latinas, and American Indians.

Research guidelines now require that a diversity of 

subjects be represented in clinical studies. Studies

directed specifically to these populations are 

important for two reasons:

• Only research protocols specifically designed 

to focus on these populations will ensure that 

sufficient numbers of high-risk women are 

studied to adequately answer the questions 

posed by a study.

• Women in high-risk groups may have distinguishing physiologic, behavioral, or environmental 

characteristics that place them at increased risk 

for cardiovascular disease and that increase the

severity of complications following treatment 

or invasive procedures. Only through studies

designed specifically for these population groups 

can these characteristics be elucidated and 

methods devised to address and ameliorate them.

Impact of Patient and Health Care Professional

Behaviors on Cardiovascular Disease Development

and Prevention in Women

Despite the fact that risk factors for cardiovascular disease have been well known for years, heart

attack, stroke, and other cardiovascular diseases 

in women have not been recognized as a serious 

problem until recently, particularly by women 

themselves. Considerable information has been 

published for the general public and health care 

professional audiences on heart disease prevention 

and treatment, but it appears that these audiences 

are not acting on this information.

There are still significant gaps

in knowledge about the determinants of behavior related to cardiovascular disease among patients, 

the public, health care professionals, and policy makers. Understanding these determinants more fully

will permit development of more

effective information materials, interventions, and support strategies.

TABLE 4. Women’s Perceived and Real Health Risks

PERCEPTION PERCENT CAUSE OF DEATH PERCENT

Breast cancer 46 Heart disease 34

Unspecified cancer 16 Other cancer 12

Heart disease 4 Stroke 8

AIDS 4 Lung cancer 5

Uterine/Ovarian cancer 3 Breast cancer 4

Source: Vital Statistics of the U.S., National Center for Health Statistics
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

The hope is that these will lead, in turn, to improved

preventive behaviors and improved compliance with

heart disease treatments.

RESEARCH 

RECOMMENDATIONS

The consensus of the Cardiovascular Diseases

Working Group was that recommendations for 

cardiovascular disease research should center 

around the five identified major gaps in knowledge. Furthermore, the research conducted should

encompass the biomedical spectrum from basic 

laboratory research to applied research, and from 

the individual to the public health level. 

Developmental Biology of the Vascular System 

and Role of Fetal Environment in Programming 

Lifelong Cardiovascular Function

• Understand the ways in which suboptimal 

conditions in utero may lead to prenatal 

programming of cardiovascular function 

throughout life and the ways in which 

environmental influences can affect the 

expression of different genes to result 

in altered phenotype.

• Evaluate the interaction of nutrition 

and cardiovascular development, using 

animal models.

• Study the maturation of central nervous 

system functions and how they regulate the 

functioning of the cardiovascular system.

• Explore the interrelationship of renal 

development and cardiac function.

Molecular and Physiologic Mechanisms of 

Hormone Action in the Cardiovascular System

• Characterize estrogen receptors in vascular 

tissue and vascular cells, including vascular

endothelial cells and smooth muscle cells.

• Identify the relative amounts of mRNA 

and protein for estrogen receptor alpha 

and estrogen receptor beta in different 

vascular cells and beds, in women versus 

men, in premenopausal versus postmenopausal women, and in the presence or 

absence of hormone replacement therapy.

• Study molecular mechanisms of estrogen 

action in vascular cells, with an emphasis 

on novel pathways in vascular cells, including ligand-independent activation of vascular 

estrogen receptors, and vascular cell coactivator and corepressor molecules.

• Examine molecular mechanisms of estrogen’s

nongenomic vasodilatory effect on the vasculature and estrogen’s longer-term effects to 

inhibit atherosclerosis and the response to 

vascular injury, using molecular, cellular, 

and animal models, with an emphasis for 

the latter on transgenic models of estrogen 

receptor function.

• Identify and study vascular genes regulated 

by estrogen, including identification of novel 

vascular gene targets of estrogen and study 

of vascular estrogen response elements in 

these genes.

• Characterize and study other steroid hormone

receptors in the vasculature and their gene 

targets, including progesterone receptors in 

the vasculature of women and men, and 

androgen receptors in the vasculature of 

women and men.

Cardiovascular Implications of Diabetes and Obesity

• Develop and evaluate strategies to improve the 

outcome of women with diabetes. This should

span the spectrum from the molecular evaluation

of insulin and glucose on endothelium and other

aspects of blood vessel function to optimizing

treatment for women with diabetes.
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VOLUME 2

• Study the interactions between estrogen and 

diabetes on blood vessels and the heart, and 

the potential role of estrogen replacement 

therapy in protecting postmenopausal diabetic

women from developing cardiovascular disease.

• Examine the impact of aggressive modification 

of other risk factors on cardiovascular outcomes 

in diabetics.

• Study prenatal precursors to obesity.

• Study genetic, molecular, and hormonal factors 

in obesity and why they cause obesity to be a

greater problem in women than in men.

• Examine environmental factors that are important in the expression of a predisposition to 

obesity, and the development of approaches 

to alter the environment so as to avoid or 

address obesity.

• Study the roles that various stages of life play 

in placing women at increased risk for obesity 

and the development of ways to address 

these risks.

• Investigate modifiable societal and community 

factors that result in increased obesity and ways 

in which to change these so that they favorably

affect the prevalence of obesity.

• Study effective therapeutic modalities to treat 

obesity, in particular the role of physical activity 

in reducing or preventing obesity.

Prevention, Detection, and Management of 

Cardiovascular Disease in High-risk Populations

• Examine the dimensions of cardiovascular 

disease in high-risk populations, including 

women who are octogenarians and older, 

racial and ethnic minorities, and disabled 

women. In recruiting subjects, investigators 

should cast a broad geographic and socioeconomic net, and should incorporate these 

variables into the hypotheses to be studied. 

A critically important element of this area 

of research should be devising logistics and 

methods that will improve recruitment and 

retention into clinical studies of women in 

these high-risk groups.

Impact of Patient and Health Care Professional

Behaviors on Cardiovascular Disease Development

and Prevention in Women

• Evaluate why the general public, patients, 

and health care professionals do not act on 

well-known prevention information despite 

its widespread availability.

• Determine exercise, nutrition, smoking, and 

other lifestyle behaviors related to the development of cardiovascular disease among 

women patients.

• Develop methods to increase the effectiveness 

of cardiovascular disease prevention interventions and education efforts.

• Evaluate the education, prevention, diagnostic,

treatment, and management procedures followed

by health care professionals with respect to cardiovascular disease and how these differ by 

gender, age, race, and ethnicity of patients.

References

1 American Heart Association. 1998 Heart and Stroke 

Statistical Update. Dallas (TX): American Heart 

Association, 1998.

2 Hayman LL. Testimony presented on behalf of the 

American Heart Association at a public hearing at: 

“Beyond Hunt Valley: Research on Women’s Health 

for the 21st Century”; 1996 Sep 25; Philadelphia, PA.

Hearing and workshop sponsored by the Office of

Research on Women’s Health, National Institutes of 

Health; University of Pennsylvania School of Medicine;

Allegheny University of the Health Sciences; and MCP

Hahnemann School of Medicine. 
80

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

3 Lenfant C. Heart disease research in women: A look 

back and a view to the future. Talk presented at: 

“Beyond Hunt Valley: Research on Women’s Health 

for the 21st Century”; 1997 Nov 17-19; Bethesda, 

Md. Hearing and workshop sponsored by the Office 

of Research on Women’s Health, National Institutes 

of Health.

4 Rifkind BM, Rossouw JE. Of designer drugs, magic 

bullets, and gold standards [editorial]. JAMA;279:

1483-85.

5 Iafrati MD, Karas RH, Aronovitz M, Sullivan TR Jr, 

Lubahn DR, O’Donnell TF Jr, Korach KS, Mendelsohn 

ME. Oestrogen inhibits the vascular injury response 

in oestrogen receptor-deficient mice. Nature Medicine

1997:3:545-548.

6 Mendelsohn ME, Karas RH. Estrogen and the blood 

pressure wall. Curr Opin Cardiol 1994;9:619-626.

7 Mendelsohn ME, Karas RH. Mechanisms of disease: 

the vascular protective effects of estrogen. N Engl J Med

1999 (in press).

8 Pennisi E. Differing roles found for estrogen’s two 

receptors [Research News]. Science 1997;277:1439.
DIGESTIVE DISEASES

BACKGROUND

Recent research has yielded important 

information on gender differences in 

digestive diseases. Gender-based differences have been identified in several areas, including irritable bowel syndrome and other functional

bowel disorders, colorectal cancer detection, gallstone disease, liver disease, and metabolic bone 

disease. The discovery of genetic bases in certain 

colon cancers, gallstone disease, and liver diseases 

is another advance of vital importance. Much work

remains to be done, however.

Digestive diseases were included for the first 

time as a separate working group at the November

1997 ORWH conference. This afforded attendees an

opportunity to focus on these diseases and how they

affect women as well as men. While there was much

progress to discuss, significant gaps in knowledge 

and the pressing need for further research were 

also identified. 

The working group focused its discussions 

primarily on irritable bowel syndrome, functional

bowel disorders, colorectal cancer, gallstone disease,

and selected liver diseases. This report also highlights knowledge gaps, issues, and research needs 

pertaining to peptic ulcer disease, metabolic bone 

disease, digestive diseases during pregnancy, and

women in the field of gastroenterology.

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

Since 1991, significant progress has been made

toward understanding the etiology and mechanisms 

of many of these diseases and how they affect men 

and women differently. In the area of irritable bowel

syndrome and functional bowel disorders, advances

have included an increased understanding of the 

functions of specific brain peptides, nitric oxide, 

carbon monoxide, and other factors in gastrointestinal motility, a key mechanism involved in these 

conditions. Progress has also been made in relating 

elements such as sensory dysfunction, pelvic floor 

dysfunction, motor dysfunction, and psychosocial 

factors, including physical and sexual abuse, to 

such disorders.

Regarding colorectal cancer, four distinct genes

have been identified that, when inherited in altered

form, cause increased susceptibility to colorectal 

cancer at unusually early ages. Some of these gene

alterations have been associated with increased risk 

of colorectal cancer alone, but others have been 

associated with a higher risk of developing other

tumors as well, including pancreatic, small bowel, 

and endometrial cancers, and possibly ovarian 

and breast cancers. A further advance has been 

the identification of a gene associated with familial

adenopolyposis. In the area of screening for colorectal cancers, studies have shown that screening with

Cochairs

James E. Everhart, M.D., M.P.H.

National Institute of Diabetes and 

Digestive and Kidney Diseases

National Institutes of Health 

Joanne A.P. Wilson, M.D., F.A.C.P.

Duke University Medical Center

Jacqueline Wolf, M.D.

Brigham and Women’s Hospital

Rapporteur: Joanne B. Brodsky

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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

fecal occult blood testing or sigmoidoscopy is associated with decreased mortality from these cancers. 

As of January 1, 1998, Medicare enrollees receive 

coverage for colorectal cancer screening. This 

recognition of the benefits of colorectal cancer 

screening is an exciting development with the 

potential to save many lives. 

A number of advances have been made that 

relate to gallstone disease. These include identification in an animal model of genes associated with 

the disease. This finding may be helpful in determining the genetic inheritance of gallstone disease 

in humans. The evolution of laparoscopic cholecystectomy as the most common technique for 

gallbladder removal has been associated with a 

significant decrease in morbidity and more rapid 

recovery rates for patients, because surgery is 

performed through three small incisions and 

the abdominal cavity does not have to be opened 

further. Recent work has fostered a greater understanding of the physiological role of the gallbladder in gallstone formation, as well. This increased 

understanding may lead to better prevention and 

treatment techniques for this common disorder. 

A further development in this area has been the 

discovery that certain drug therapies may prevent 

the formation of gallstones in patients experiencing rapid weight loss, a group at high risk for 

this problem. 

The identification of a genetic defect that 

accounts for a large proportion of cases of acute 

fatty liver of pregnancy may lead to significant 

reductions in maternal and fetal mortality from this

condition. Recent research has also lead to a greater

understanding of the mechanisms of nonsteroidal 

anti-inflammatory damage to the gastrointestinal 

tract, along with a greater understanding of the 

mechanism for cytoprotection of the gastric mucosa.

Some of the causes and extent of the problem of 

bone disease in inflammatory bowel disease have 

also been brought to light by recent work. This has 

led to the recognition that osteoporosis is common

among inflammatory bowel disease patients and 

has highlighted the need for targeted treatment 

for such patients. 

GAPS IN KNOWLEDGE

Colorectal Cancer

Colorectal cancer is the second deadliest cancer in the United States and the third leading cause

(behind lung and breast cancer) of cancer deaths in

women. Of the 140,000 new colon cancer cases in 

the United States each year, 60,000 occur in women.

(See Figure 1.) Thirty thousand women die each year

of colon cancer in the United States. This figure is 

far greater than the number of cervical cancer deaths

each year in this country, yet the general public 

seems less aware of colorectal cancer.

Hereditary colon cancer accounts for some 

15 percent of all colon cancers. Studies of patients 

with hereditary colon cancer have shown that women

are more at risk than men for developing associated

malignancies. As noted above, the associated malignancies include pancreatic, small bowel, and endometrial

cancers, and possibly ovarian and breast cancers. 

Further study of families with inherited colorectal 

cancers may provide valuable information regarding

the possible etiology of the associated cancers and 

why they develop in some cases and not in others.

FIGURE 1. Gender Differences in Colon Cancer

Sources: Ries LAG, Hankey BF, et al., eds. SEER Cancer Statistics

Review, 1973-1991. National Cancer Institute. 1994.

60

40

20

0

6

4

2

0

FEMALES FEMALES MALES MALES

Colon Cancer Incidence

(cases/100,000/yr.)

Lifetime Colon Cancer at Risk

(%):
83

VOLUME 2

From a public health standpoint, there is a 

pressing need to increase awareness of colon cancer

and to encourage greater participation in colorectal

screening programs. While many women are being

screened for breast and cervical cancer, far fewer

receive screening for colorectal cancer. The rate 

of sigmoidoscopy screening is significantly lower 

for women than for men. This is unfortunate in 

that early screening for colorectal cancer is highly 

effective in actually preventing new cases of colon 

cancer because growths can be discovered and

removed before they become cancerous. Thus, 

strategies are needed to make the medical community and the public more aware of the importance of screening women and men for colorectal 

cancer. (See Figure 2.)

Irritable Bowel Syndrome and Functional 

Bowel Diseases 

Irritable bowel syndrome and functional 

bowel diseases affect 15 to 20 percent of the U.S. 

population. Two to three times as many women 

as men suffer from these conditions. Symptoms 

include abdominal pain, changes in bowel habits, 

gas, and bloating. Irritable bowel syndrome is estimated to be responsible for some 20 to 50 percent 

of referrals to gastroenterology clinics. A recent 

study indicated that individuals with irritable 

bowel syndrome miss 13.4 days of work per year, 

compared with the national average of 4.9 days 

missed. Health care costs for such patients have 

been found to be significantly higher, as well. Data

indicate that irritable bowel syndrome patients are 

also at greater risk for unnecessary surgery.

Recent studies have yielded epidemiological, 

physiological, and psychosocial data that have led 

to an improved understanding of these disorders 

and their treatment. They are now thought to be

biopsychosocial in nature and to involve the interaction of three major mechanisms: psychosocial 

factors (e.g., life stress, sexual and physical abuse, 

psychiatric disorders), altered motility in the small

intestine or colon, and increased sensitivity to 

pain and other sensations.

Further studies aimed at clarifying the causes 

and mechanisms of these disorders are needed so 

that effective treatment strategies can be developed.

Specifically, existing tools need to be standardized 

and new technologies developed in the areas of 

evaluating and categorizing patients, identifying 

disease mechanisms, targeting specific behavioral 

and medical therapies, and better educating professionals, patients, and the general public. 

Gallstone Disease

Gallbladder and biliary tract disease from 

gallstones are major causes of disease and death 

in the United States, with some 20 million people 

estimated to have symptomatic or asymptomatic 

gallstones. (See Figure 3.) These conditions occur 

twice as frequently in women as they do in men. 

(See Figure 4.) More than 500,000 cholecystectomies 

a year are performed in this country, and gallbladder

removal is one of the most common surgeries performed on women. These conditions represent a 

significant health care expense, totaling more 

than $8 billion annually.

Three mechanisms are thought to favor the 

development of gallstones in women: the effect 

of estrogens on the uptake and metabolism of 

FIGURE 2. How Many Cancer Deaths Per Year Could 

Be Prevented by Universal Screening?

Sources: Ries LAG, Hankey BF, et al., eds. SEER Cancer Statistics

Review, 1973-1991. National Cancer Institute. 1994.

0

5,000

10,000

15,000

20,000

BREAST COLON CERVICAL
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

cholesterol in the liver, inhibition of gallbladder 

motility during pregnancy, and increased 

cholesterol saturation of bile during periods of 

weight loss, which is more common among women

than men. Better understanding of the importance 

and interactions of these and perhaps other factors will be critical to the development of rational

approaches to the prevention of gallstones.

Evidence suggests that gallstone disease may 

be familial in humans, and further studies are needed

to test this hypothesis. Recent studies have identified

genes that are responsible for gallstone formation 

in mice. Additional work is needed to determine

whether there is a genetic basis for such disease in

humans. Further elucidation of the role played by

estrogens and progesterones in the formation of 

cholesterol stones is also needed, along with a 

greater understanding of the natural history of the 

disease in women. Better understanding of the 

basic biology of the disease and the development 

of strategies to prevent gallstone formation could 

contribute greatly toward patient welfare and 

decreased health care expenditures.

Nonsteroidal Anti-inflammatory Drugs and 

Peptic Ulcer Disease

High dosages of nonsteroidal anti-inflammatory

drugs (NSAIDs) are a known cause of peptic ulcer 

disease in both men and women. Examples of these

medications include aspirin and ibuprofen. Women

tend to take more of these medications than do men

because they suffer more from degenerative arthritis

and pelvic pain. Older women, in particular, use 

these drugs heavily and are therefore at higher risk 

for gastrointestinal ulceration and bleeding. Prostaglandin analog (misoprostol) has been shown to decrease the risk of NSAID-induced gastritis and ulcers,

but has diarrhea as a major side effect. Further information is needed on how to prevent NSAID-induced

peptic ulcer disease in both women and men.

Liver Disease 

Autoimmune Liver Disease. The two principal

autoimmune liver diseases, primary biliary cirrhosis

and autoimmune hepatitis, are much more common 

in women than in men. Primary biliary cirrhosis 

0

5

10

15

20

25

30

■ FEMALES

■ MALES

Source: Third National Health and

Nutrition Examination Survey

FIGURE 3. Age-adjusted

Prevalence of Gall Bladder

Disease Among Adults

According to Ethnicity

and Sex

U.S. Whites Mexican Americans Blacks
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VOLUME 2

occurs nine times more frequently in women than 

men and primarily affects middle-aged women.

Although not a common disease, primary biliary 

cirrhosis causes substantial morbidity from chronic

fatigue, pruritus (severe itching), and skeletal fractures. More importantly, primary biliary cirrhosis 

is a leading cause of end-stage liver disease and is 

the most common reason for liver transplantation 

in women. The main autoimmune marker for primary biliary cirrhosis is serum antimitochondrial 

antibody. Although this antibody is present in 

90 percent of primary biliary cirrhosis patients, its

pathophysiological importance remains to be determined. Inflammation and subsequent loss of small 

bile ducts within the liver are the main findings 

upon liver biopsy. Intense investigation is needed 

to understand the causes of the bile duct injury 

and why it progresses to cirrhosis and liver failure. 

This work will have important implications for 

this disease and for understanding injury to bile 

ducts in many disorders. Treatment with the bile 

acid ursodiol is modestly effective in preventing 

transplantation and death, but more effective 

therapy is needed.

Autoimmune hepatitis affects women three to 

four times as often as it does men. This disease is 

associated with a number of other autoimmune 

conditions (such as thyroiditis and Sjögren’s syndrome) and with several autoantibodies. However, 

even less is understood about the causes of autoimmune hepatitis than primary biliary cirrhosis. The

hepatitis is often severe and leads to liver failure 

if left untreated. The mainstay of treatment for 

many years has been glucocorticoids, which are 

often required in high doses for extended periods.

Because of the complications and occasional ineffectiveness of these drugs, better therapies are needed.

Research into the etiology and mechanisms of this 

disorder could have important implications for 

understanding the immune response and hepatic

inflammation.

Nonalcoholic Steatohepatitis. Nonalcoholic 

steatohepatitis is an important liver disorder that 

has been recognized as a distinct entity only within 

the last 15 years. This disorder has all the histological characteristics of alcoholic liver disease, including

large accumulations of fat, acute and chronic inflammation, and fibrosis and cirrhosis. Nonalcoholic 

0

5

10

15

20

25

■ FEMALES

■ MALES

Source: Jorgensen T. Prevalence of

gallstones in a Danish population. 

Am J Epidemiol 1987; 126: 912-21.

30 Years of Age

Percent with Gallstone Disease

40 Years of Age 60 Years of Age 50 Years of Age

FIGURE 4. Woman 

Are at Higher Risk of 

Gallstone Disease
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

steatohepatitis is a common reason for elevated liver

enzyme tests and may be the most common cause 

of liver disease in women. Risk factors are thought 

to be obesity and non-insulin-dependent diabetes 

mellitus, which are both disorders of insulin resistance. However, much about the cause, pathogenesis,

and natural history of nonalcoholic steatohepatitis

remains to be determined. It is quite possible that

many of the patients — especially women — who

arrive at transplantation with so-called cryptogenic 

cirrhosis may have nonalcoholic steatohepatitis as 

an important contributing cause. To date, there is 

no established treatment. With the increasing prevalence of diabetes and obesity in the United States, 

particularly among minority women, nonalcoholic

steatohepatitis can be expected to become an 

increasingly important problem.

Metabolic Bone Disease

Osteoporosis, or loss of bone mass, affects 

both men and women, but advances more rapidly in

women, especially after menopause. Some 25 million

Americans suffer from this condition, which may 

result in bone fractures and a loss of skeletal support.

In the United States, more than 1 million fractures 

per year are attributed to osteoporosis. Osteoporosisrelated debilitation and death account for $7 to $10

billion in annual health care costs. Maintaining adequate calcium absorption through the intestines 

is a critical factor in preventing osteoporosis. 

Patients with inflammatory bowel disease are 

at increased risk for osteoporosis, due in part to a

decreased ability to absorb calcium as a side effect 

of the corticosteroid therapy that is often used to 

treat inflammatory bowel disease, and because of 

the presence of increased cytokines, which probably

have a direct effect on the bone. Hormone replacement therapy has shown some promise in lessening 

the severity of osteoporosis among these patients. 

Further work is needed to develop better osteoporosis prevention and treatment strategies for patients

with inflammatory bowel disease. 

Bone loss is also a common and significant 

problem among patients with the chronic liver 

disease, primary biliary cirrhosis. Osteoporosis develops early among such patients, and related spine 

and hip fractures often contribute to their deaths.

Because primary biliary cirrhosis primarily affects

women, and women are more susceptible to osteoporosis, this is an important women’s health issue.

Recent findings indicate that progressive bone loss 

is halted and sometimes reversed in primary biliary 

cirrhosis patients following liver transplantation. 

(Bone loss was found to worsen immediately following transplantation, but then improved. The initial 

high doses of steroids that are included in immunosuppression therapy may be responsible for this 

temporary worsening.)

Osteoporosis and osteopenia, conditions 

that are distinguished by the amount of bone loss

involved, accompany other chronic liver diseases, as

well. Improved methods are needed to evaluate and

treat bone loss in chronic liver disease patients. 

Digestive Diseases During Pregnancy

Digestive problems during pregnancy largely 

fall into two categories: (a) chronic conditions that

exist before the patient becomes pregnant and continue during the pregnancy and (b) symptoms and

conditions unique to or particularly common during pregnancy. In all cases, the sensitivity of the 

fetus to the mother’s illness and to the diagnostic 

procedures and medications used to address it 

must be given high priority.

Chronic conditions that present special 

problems during pregnancy include inflammatory

bowel disease and biliary disease. Inflammatory 

bowel disease, including ulcerative colitis and 

Crohn’s disease, is common among women of 

childbearing age. Successful management of these 

conditions correlates with successful pregnancy 

outcomes. While some patients’ symptoms improve

during pregnancy, this is not the case for most 

patients. The safety of monitoring procedures — 
“Irritable bowel syndrome predominantly 

affects women. Approximately 75 percent of 

individuals with IBS in the community are female,

with the incidence being reported as high as 90 percent in some medical centers. This is a major 

women’s health issue.”

Nancy Norton

International Foundation 

for Functional 

Gastrointestinal Disorders

87

VOLUME 2

such as ultrasound, endoscopy, MRI scans, x-rays 

and CAT scans — and medications used to treat 

these conditions during pregnancy are vitally important. Ultrasound is deemed safe, and endoscopy and

MRI scans are thought to be safe, but x-rays and 

CAT scans are not considered safe for routine use. 

Only a few medications used to treat digestive 

diseases have been established as safe for use in 

pregnancy. Whether the dose response of the medications is the same in pregnancy as in the nongravid

state is not known. Continuing efforts and better 

mechanisms to determine and ensure the safety 

of procedures and medications used to address 

these conditions are needed. 

Gallstone and sludge formation are common 

during pregnancy and are thought to be influenced 

by hormonal changes that affect biliary physiology.

Because these conditions can lead to pancreatitis 

and other complications, careful monitoring and 

treatment are required. As noted above in the section on gallbladder disease, more information is 

needed on gallstones formed during pregnancy to

develop better prevention and treatment strategies.

Common symptoms such as nausea and vomiting of pregnancy and heartburn can often be treated

with safe, conservative measures. Again, the safety of

the medications used must be continually monitored.

Hyperemesis gravidarum is nausea and vomiting during

pregnancy that is severe enough to cause systemic

effects such as dehydration, electrolyte abnormalities,

and weight loss. Hospitalization is sometimes required

to control these effects. Few studies of this condition

have been conducted. 

Recent research has enabled scientists to identify 

a genetic defect that accounts for a large percentage 

of cases of acute fatty liver of pregnancy, a rare but 

frequently fatal disease. In this condition, fat is 

deposited in the cytoplasm of hepatocytes. With 

further research, this advance may lead to a significant reduction in the rate of maternal and fetal 

mortality from this disease and may provide insight

into similar diseases such as Reye’s syndrome. 

RESEARCH 

RECOMMENDATIONS

Colorectal Cancer

• Determine how interventions such as postmenopausal estrogen therapy and low-fat diets

affect the risk of colorectal cancer in women.

• Develop more cost-effective methods for early

detection of colorectal cancer.

• Devise methods to educate women and health 

care providers to the importance of screening 

for colorectal cancer.

• Explore genetic identification of high-risk groups.

• Explore the relationship between hereditary colon

cancer and ovarian and endometrial cancers.

Irritable Bowel Syndrome and Functional 

Bowel Diseases

• Determine why these conditions affect so 

many more women than men.

• Further elucidate the mechanisms of 

gut motility.
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• Clarify smooth muscle physiology.

• Identify and characterize the influences on 

gut motility and smooth muscle physiology 

of various brain peptides and neurotransmitters

such as carbon monoxide and nitric oxide.

• Develop a clearer understanding of the 

functioning of the enteric nervous system.

• Explain how heightened sensitivity to pain 

and other sensory dysfunctions are involved 

in irritable bowel syndrome and functional 

bowel disorders.

• Examine the relationship between pelvic 

floor dysfunction and these conditions.

• Study the effects of the menstrual cycle 

on irritable bowel syndrome and functional 

bowel disorders.

• Elucidate the role of environmental and 

other stressors, developmental influences, and

biopsychosocial factors in these conditions.

• Validate diagnostic criteria.

• Further identify and target specific pharmacologic and other therapeutic interventions 

(such as stress reduction techniques, and 

alternative health interventions such as 

acupuncture and family therapies) for 

irritable bowel syndrome and functional 

bowel disorders.

In addition, care should be taken in designing patient studies to address limitations that were 

present in previous studies. Areas to be addressed

include targeting selection criteria for these conditions, grouping patients by the severity of their 

symptoms, adequacy of sample size, length of 

treatment and followup periods, and analytical 

methods used.

Gallstone Disease

• Investigate gender differences in cholesterol 

metabolism and excretion in bile.

• Explore the effects of gender on interactions

between gallbladder physiology and gut motility.

• Identify how sex hormones influence the 

expression of recently identified genetic factors.

• Elucidate the physiological functions of 

the gallbladder and factors that influence 

the gallbladder functions of motility, secretion, 

and absorption.

• Improve diagnosis and methods to identify 

patients who will develop complications 

of gallstone disease.

• Investigate the etiology and natural history 

of gallstones formed during high-risk periods 

such as pregnancy and weight loss.

• Explore the reasons for ethnic variations in gallstone disease (such as the high incidence among

American Indians and Mexican Americans).

• Investigate potential preventive measures.

Liver Disease

• Understand nonalcoholic steatohepatitis, 

including (a) ascertaining why women are 

more susceptible; (b) learning the natural 

history, including who goes on to cirrhosis; 

(c) determining the molecular mechanisms 

and genetic and environmental susceptibility 

factors; and (d) identifying treatment and 

prevention strategies.

• Explore pathogenesis, immunology, and therapeutic approaches to primary biliary cirrhosis.

• Explore influences of sex hormones on elements 

of the immune system related to autoimmune 

liver diseases.
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• Understand hepatic cell growth and investigate the influence of sex hormones on the 

proliferation of liver cells and the growth 

of tumors.

• Identify safe and effective therapies for primary 

biliary cirrhosis and autoimmune hepatitis.

Nonsteroidal Anti-inflammatory Drugs and 

Peptic Ulcer Disease

• Research and develop medications to replace 

nonsteroidal anti-inflammatory drugs to control pain from arthritis and other disorders 

because these medications have gastrointestinal ulceration and bleeding side effects. 

More women than men use these drugs, 

and therefore studies should involve women 

in sufficient numbers so as to yield meaningful information on prevention strategies 

for women.

Metabolic Bone Disease

• Better understand the mechanisms of calcium

absorption through the intestines in health 

and disease and how they change with age.

• Clarify the relationship between inflammatory bowel disease and osteoporosis and 

osteopenia in order to develop improved 

treatment modalities.

• Clarify the relationship between primary 

biliary cirrhosis and osteoporosis and 

osteopenia in order to develop improved 

treatment modalities.

• Develop better methods for evaluating and 

treating bone loss that accompanies chronic 

liver disease.

• Determine the extent to which bone loss in 

chronic liver diseases may be restored after 

liver transplantation.

Digestive Diseases During Pregnancy

• Investigate the influence of hormones on 

various digestive disorders that may be 

present during pregnancy.

• Investigate the etiology and natural history 

of gallstones formed during pregnancy.

• Determine the safety profiles in pregnancy 

of procedures used to diagnose and treat 

gastrointestinal conditions.

• Determine the safety profiles in pregnancy 

of drugs used to treat chronic gastrointestinal conditions.

• Investigate whether the absorption and 

metabolism of drugs used to treat chronic 

gastrointestinal conditions changes 

during pregnancy.

• Further clarify the causes of acute fatty 

liver of pregnancy and develop improved 

treatment and prevention strategies.

Career Issues for Women in the Field 

of Gastroenterology

• Expand support for mentoring programs 

for women.

• Encourage improvements in existing mentoring programs, including the inclusion of 

more female mentors.

• Encourage and provide funding for the 

formation of special academic tracks for 

women interested in research careers.

• Encourage academic institutions to revise 

their tenure and promotion policies in order 

to accommodate the need for family leave, leaves 

of absence, flexible scheduling, and the like.

• Encourage institutions to develop programs 

to prepare more women faculty members 

for senior administrative positions.
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• Support policies that promote the concept 

of equal pay for equal work.

• Improve NIH support for women who work 

part-time or interrupt their careers.

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Jun 1997; New Orleans, La. p. 37-43.

Amouyal G, Amouyal P. Endoscopic ultrasonography 

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Estrogen replacement therapy and risk of fatal colon cancer 

in a prospective cohort of postmenopausal women. J Natl 

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Camilleri M, Saslow SB, Bharucha AE. Gastrointestinal 

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Danze PM, Colombel JF, Jacquot S, Loste MN, Heresbach D,

Ategbo S, Khamassi S, Perichon B, Semana G, Charron D, 

et al. Association of HLA class II genes with susceptibility 

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Diehl AM. Presentation to the Digestive Diseases Working

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Bethesda, Md. Sponsored by the Office of Research on 

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Dill J, Hill S, Callis J, et al. Combined endoscopic 

ultrasound and stimulated biliary drainage in cholecystitis 

and microlithiasis: diagnosis and outcomes. Endoscopy

1995 Jul;27.

Dill J. The gallbladder, the gut, and the brain: connections 

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1997 Jun 11-13; New Orleans. p. 5.

Donovan JM, Syngal S. Colorectal cancer in women: an 

underappreciated but preventable risk. J Women’s Health

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Donovan JM. Presentation to the Digestive Diseases Working

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on Women’s Health for the 21st Century; 1997 Nov 19; 

Bethesda, Md. Sponsored by the Office of Research on 

Women’s Health, National Institutes of Health. 

Drossman DA. Chronic functional abdominal pain. 

Am J Gastroenterol 1996;91(11):2270-81.

Drossman DA, Creed FH, Fava GA, Olden KW, Patrick DL,

Toner BB, Whitehead WE. Psychosocial aspects of the 

functional gastrointestinal disorders. Gastroenterol Int

1995;8(2):47-90. 

Drossman DA, Talley NJ, Olden KW, Leserman J, Barreiro 

MA. Sexual and physical abuse and gastrointestinal illness:

review and recommendations. Ann Intern Med 1995;

123:782-94.

Drossman DA, Whitehead WE, Camilleri M. Irritable 

bowel syndrome: a technical review for practice guideline 

development. Gastroenterology 1997;112(6);2120-37.

Gorard DA, Libby GW, Farthing MJG. Effect of a tricyclic 

antidepressant on small intestinal motility in health and 

diarrhea-predominant irritable bowel syndrome. Dig Dis 

Sci 1995;40:86-95.

Greene B, Blanchard EB. Cognitive therapy for irritable 

bowel syndrome. J Consult Clin Psychol 1994;62:576-82.

Hammer J, Phillips SF, Talley NJ, Camilleri M. Effect of a 

6HT3-antagonist (ondansetron) on rectal sensitivity and 

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Jacobs EJ, White E, Weiss NS. Exogenous hormones, 

reproductive history, and colon cancer. Cancer Causes 

Control 1994;5(4):359-66.

Kampman E, Potter JD, Slattery ML, Caan BJ, Edwards S. 

Hormone replacement therapy, reproductive history, and 

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States. Cancer Causes Control 1997;8(2):146-58.

Kay L, Jorgensen T, Jensen KH. The epidemiology of 

irritable bowel syndrome in a random population: prevalence, incidence, natural history and risk factors. J Intern 

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LeBoff MS. Is prolonged use of corticosteroids safe in 

patients with Crohn’s disease? Inflammatory Bowel Dis

1997;3(2):169-73.

Mayer EA, Gebhart GF. Basic and clinical aspects of 

visceral hyperalgesia. Gastroenterology 1994;107:271-93.

McKenzie SJ, Baker MS, Buffinton GD, Doe WF. Evidence 

of oxidant-induced injury to epithelial cells during inflammatory bowel disease. J Clin Invest 1996;98:136-41.

Mertz H, Naliboff B, Munakata J, Niazi N, Mayer EA. 

Altered rectal perception is a biological marker of patients 

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Advances, 1992-1997. National Institute of Diabetes and 

Digestive and Kidney Diseases, National Institutes of Health.

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and risk of large-bowel cancer. J Natl Cancer Inst 1995;

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Gastrointest Endosc Clin North Am 1994;4(4):699-712.

Risch HA, Howe GR. Menopausal hormone use and 

colorectal cancer in Saskatchewan: a record linkage cohort

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Szurszewski J. Presentation to the Digestive Diseases 

Working Group on gut motility at: Beyond Hunt Valley:

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Nov 18; Bethesda, Md. Sponsored by the Office of Research 

on Women’s Health, National Institutes of Health.

Talley NJ, Gabriel SE, Harmsen WS, Zinmeister AR, Evans 

RW. Medical costs in community subjects with irritable 

bowel syndrome. Gastroenterology 1995;109(6):1736-41.

Toner BB. Cognitive-behavioral treatment of functional 

somatic syndromes: integrating gender issues. Cognitive 

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factors in irritable bowel syndrome. Can J Psychiatry

1990;35:158-61.

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Research on Women’s Health, National Institutes of Health;

1996 Sep 26-27; Philadelphia, Pa; p. 85-91.

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Beyond Hunt Valley: Research on Women’s Health for 

the 21st Century; 1997 Nov 17; Bethesda, Md. Sponsored 

by the Office of Research on Women’s Health, National 

Institutes of Health.

IMMUNITY AND 

AUTOIMMUNE DISEASES

BACKGROUND

Women’s health depends significantly on

the appropriate function of the immune

system. Asthma and allergic diseases 

are important sources of morbidity in women. Autoimmune diseases, in which the immune response is

directed at the body’s own tissues, disproportionately

afflict women. In addition, the immune response is

important in protection against many infections, such

as sexually transmitted diseases, and their sequelae. 

In addition to the traditional immune-mediated diseases, many diseases are now recognized to have an

immune or inflammatory component. These include

atherosclerosis, Alzheimer disease, and many neurologic diseases. Evidence exists that there may be differences in the function of men’s and women’s immune

systems, including the fact that women are able to 

tolerate without rejection a fetus during pregnancy. 

Autoimmune diseases, including rheumatoid

arthritis, systemic lupus erythematosus, multiple 

sclerosis, scleroderma, Sjögren’s syndrome, autoimmune thyroid disease, type 1 diabetes, idiopathic

thrombocytopenia purpura, and inflammatory bowel

disease, can affect every organ system. Many of these

diseases are considered rare, that is, affecting less 

than 200,000 individuals. However, in toto, millions 

of women in the United States are afflicted by autoimmune diseases, leading to billions of dollars in health

care costs per year. Because many of these diseases

affect young women, there is significant impact on 

the health of families and lost productivity. 

The Working Group on Immunity and Autoimmune Diseases consisted of researchers, clinicians,

patients, and advocates who discussed advances in

immunology since the first Hunt Valley meeting in 

September 1991. In addition, the group identified 

several gaps in our knowledge in this area. Many of

these areas offer opportunities for increased emphasis

in the coming years with significant likelihood for 

discoveries that will improve the health of women.

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

In the years since the establishment of ORWH 

in 1990, the scientific community has made notable

progress in several areas of immunological research.1

Researchers have gained new understanding of many

areas of basic immunology including: the degradation

of antigens intracellularly and their presentation to 

the immune system; the identification of subtypes 

of T cells and their role in immune activation and 

regulation; the development of B cells and their role 

in cellular immune responses; identification of many

soluble molecules including cytokines and chemokines, and their role in the immune response; the 

trafficking of immune cells to various areas of the

body; inter- and intra-cellular signaling cascades; 

and the pathways leading to cell death. In addition,

there have been significant new insights in our 

understanding of the interactions of the various 

components of the immune system. Furthermore,

recognition that the immune system plays a critical 

Cochairs

Elaine Collier, M.D.

National Institute of Allergy and Infectious Diseases

National Institutes of Health 

Betty Diamond, M.D.

Albert Einstein College of Medicine

Anita Corman Weinblatt, Ph.D.

Division of Research Grants

National Institutes of Health

Caroline Whitacre, Ph.D.

Ohio State University

Rapporteur: Kimberly C. Mitchell, M.P.H.

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role in many diseases that were not previously 

thought to be immunologically mediated has 

increased the need to understand immune function throughout the life span.

Tools and Methodological Advances 

Much of the progress in the field of immunology

has been possible because of the development of new

research tools, which have had a significant impact 

on many areas of science. One of these tools, polymerase chain reaction, has allowed the measurement 

of very small amounts of material and facilitated the

manipulation of DNA, which has been critical for 

the development of many other tools. The study 

of known molecules in the whole animal has been 

possible with genetically engineered animals — 

both transgenic and knock-out (or knock-in) mice.

Analysis of large numbers of samples has been facilitated by synthetic and recombinant peptide libraries

and will be further advanced with microchip technology. The screening of defined populations for 

genetic differences has been possible with the development of large patient and family repositories, as 

well as newer genetic screening and sequencing 

methods. New methods of analyzing data, including

meta-analysis, have allowed new hypotheses to be

developed by combining data from many studies.

Thus, methodological, technical, and resource 

advances have permitted planning of experiments 

that previously were not possible. These developments have increased understanding of the immune

response, but also disclosed its complexity, adding

many new molecules and pathways.

Emerging Areas of Research

Recently, several previously unrecognized areas

have emerged as important in the development of the

immune response. Many of these have special importance for women’s health. In particular, the following

new areas of investigation are especially notable. 

Neural-endocrine-immune interactions. 

There has been considerable progress in understanding the molecular and cellular mechanisms involved 

in interactions between the neural, endocrine, and

immune systems. In particular, immune cells have 

been shown to synthesize and respond to neurotransmitters and hormones, neural cells synthesize and

respond to cytokines, and endocrine cells respond 

to cytokines. Also, many hormones have been found 

to be members of neurotransmitter and cytokine 

families. The overlap and similarities in these systems

have led to a recognition of molecular interactions,

which could explain previously described clinical

observations of the interactions of these systems.

Mucosal immunity. The mucosal immune 

system, composed of the gut, respiratory, reproductive, and urinary mucosa, is the first site of contact

with pathogens as well as benign foreign antigens,

including food and sperm. Understanding of the 

mechanisms leading to immunity or tolerance to 

these antigens may allow development of new 

methods to induce immunity to infectious agents 

or tolerance to self antigens, which could prevent 

or treat autoimmune diseases. Whether differences 

in the mucosal immune system exist between men 

and women has not been fully investigated. This 

could have implications for understanding sexually

transmitted diseases (STDs), allergy, vaccine development, and tolerance induction (including both nasal

and oral tolerance).

Microchimerism. The survival of cells of another

individual (fetal, maternal, or transplant) in a normal

host has only recently been appreciated within the 

scientific community. The implications of this exposure to foreign antigens for immune function and 

disease need further exploration.

Hormone receptors and their regulatory roles.

The greater incidence and prevalence of autoimmune

diseases in women has not been explained. Recently,

the findings of sex hormone receptors in immune 

cells and the regulation of transcription of cytokine

genes by sex hormones have suggested mechanisms 

by which hormones may influence the immune

response. With the cloning of sex hormone receptors, including the recent identification of a second
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estrogen receptor, the molecular tools are emerging 

to examine the role of hormones in the immune

response. It is likely that additional hormone receptors will be identified, as have many new molecules 

in the immune response. The identification of genes

regulated by hormones may offer insight into novel

influences on the immune system. The use of exogenous estrogens in oral contraceptives and hormonal

replacement therapy, drugs that include modified 

hormones for therapeutic purposes, and the presence

of phyto-estrogens from the environment should be

examined for their interaction with the immune

response. In addition, the cyclical changes in hormones in the female may have unique influences 

on the immune system.

Advances in Immune Physiology

In the years since 1991, there have been 

tremendous increases in our understanding of 

normal immune physiology and also its dysregulation in disease. These advances offer great promise 

for further understanding of disease etiology, prevention, and treatment. In particular, the increased 

understanding of the immune response offers encouragement that autoimmune and allergic diseases can 

be prevented with immune intervention. An understanding of genetic, environmental, and hormonal

influences on the immune system should be possible. Areas of particular advances include:

Antigen processing and presentation. 

The pathways, enzymes, and proteins involved 

in degradation and binding of endogenous and 

exogenous antigens with the MHC molecules have

been clarified. Recently, it has been appreciated 

that non-protein antigens can also be recognized 

by the immune system.

Inflammatory mediators. A host of molecules made by pathogens are capable of activating or amplifying an immune response. In addition,

immune and other cells may secrete molecules that

modulate the immune response. These include 

adjuvants, prostaglandins, complement proteins, 

and acute phase response molecules. Cytokines 

and chemokines are listed separately (see below).

Immune deviation. The response of immune 

cells is influenced by the cytokine environment, the

cells that are present, and the manner of activation.

Thus, the conditions during T cell activation can 

determine the immune response that is generated. 

The ability to shift the immune response may allow

development of better vaccines or the prevention 

of autoimmune disease. 

Costimulation. It is now recognized that 

interaction of the T cell receptor with the antigenMHC complex or of the B cell with antigen is not 

sufficient to activate the T or B cell. Interaction 

of additional molecules, called co-stimulatory molecules, are needed. Blocking these interactions will 

prevent activation of the cells. The elucidation of 

the necessity of these interactions offers promise 

for manipulation of the immune response to 

prevent or treat disease.

Cell signaling. Increased understanding 

of the multiple pathways of intracellular signaling 

and their interactions has emerged. These complex 

cascades of molecules represent new targets for 

therapeutic interventions to modulate the immune

response. It is likely further pathways will be 

discovered in the coming years. 

Cytokines, chemokines, and their receptors.

The number of soluble mediators of the immune

response continues to grow. In addition, our understanding of their role in the immune response is 

being clarified. Administration of these molecules 

or antibodies to these molecules are now being 

utilized for treatment of various diseases, including autoimmune diseases.

Cell trafficking. Movement of immune cells 

to and from the vasculature, lymphatics, or tissues 

is a highly regulated process that is beginning to be

understood. Modification of these movements may

modulate the immune response.
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Tolerance induction. Tolerance occurs when 

the immune system does not respond to an antigen.

This process is part of the body’s own mechanism 

to protect against autoimmunity. Increased understanding of this non-responsiveness of the immune 

system offers opportunities to prevent autoimmune 

or inflammatory diseases. 

T cell receptor and antibody gene rearrangement. Through this process of gene rearrangement,

cells dedicated to response to certain antigens are

formed and available if needed. Understanding this

process has increased our knowledge of the mechanism of response to antigen. 

Advances in Understanding Cell Differentiation 

and Death

The isolation of stem cells and the ability to 

modulate their differentiation has been a significant

advance. These studies have already been translated

into clinical interventions improving bone marrow

transplantation and immune reconstitution following

chemotherapy or radiation therapy. In addition, they

offer possibilities for treatment of autoimmune disease. 

Turnover of cells, with some increasing and 

others dying, is a necessary part of the immune

response. Considerable progress has been made in

understanding the pathways leading to cell death

(apoptosis) or survival. Investigators are now beginning to explore the molecular basis for cell death —

learning which molecules cause cells to die, which

ones prevent cells from dying, and which ones 

trigger shifts in the cell cycle. Most importantly, 

immunologists have now begun to appreciate the 

role of cell death in controlling autoimmunity and 

in regulating the normal inflammatory response.

GAPS IN KNOWLEDGE

Numerous areas offer opportunities for significant advances with promise to yield new insights 

and new strategies for clinical interventions.

Genetics and Genomics of Immune-mediated Diseases 

Repositories for DNA from patients and families

with immune-mediated diseases offer resources to 

identify susceptibility and resistance genes for these

diseases, including those that are polygenic. Linkage 

of genetic information to careful analyses of clinical

parameters — disease severity, disease subset, ethnic

background, response to therapy, and response to 

environmental triggers, among others — offers the 

possibility to prevent disease or customize treatment.

These resources also allow identification of genes 

that alter thresholds for immune activation or tolerance induction. However, very few large repositories 

or collections of families that are available to all investigators exist for numerous autoimmune diseases. 

Environmental Influences

It is now clear that many external influences 

may alter immune function in an individual. An 

understanding of the interface between aspects of 

daily living and disease risk is of critical importance 

in preventive medicine. The principal factors related 

to immune function include:

• Diet, vitamins

• Previous or concurrent infections

• Stress

• Environmental estrogens — including estrogen

replacement therapy, birth control pills

• Indoor and outdoor allergens

• Microchimerism (in pregnancy 

and transplantation)

• Lifestyle (physical activity and exercise, sexual 

orientation, etc.)

• Implanted devices

Sexual Dimorphism and Age

A significant amount is known about immune

physiology in the adult, and there is some information about differences in immune function in children

and neonates. However, no systematic information

exists concerning differences in immune physiology

based on gender and stage of life. In particular, are
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there differences in immune function in the fetal, neonatal, pubertal, mature woman, and postmenopausal

woman? Are there differences in immune function 

during various parts of the menstrual cycle? This information may allow basic scientists and clinicians to

develop more practical disease treatments. For example, some existing data suggest that tailoring asthma

therapy to the menstrual cycle can significantly decrease

both the cost and the side effects of asthma therapy.

Pregnancy

Previous investigations have looked at pregnancy

outcome in women with autoimmune diseases, but 

few studies have examined the consequences of pregnancy for the disease process both during and after

pregnancy. However, it has been observed that rheumatoid arthritis and multiple sclerosis improve during

pregnancy, whereas systemic lupus erythematosus worsens. The underlying basis for this improvement or

worsening of disease is not well understood. In addition, pregnancy as a risk factor for development of 

later disease is underexplored. Recent studies suggest

microchimerism, induced by pregnancy, is increased in

women with scleroderma. It is unclear if this is causal.

The effect of fertility enhancement and prevention on

the immune response has not been investigated. 

Hormonal Effects

The tools now exist for a dramatic increase in

knowledge regarding hormonal effects on all aspects 

of immune function, including in neonates when 

there is a transient increase in sex hormones, during puberty, during the menstrual cycle, and after

menopause. Opportunities to increase the effectiveness of vaccines or to minimize the side effects of 

therapies will depend upon increased understanding 

of immune function during physiologic alterations 

in hormone levels. Some of the most significant

research opportunities in this area include: identification of hormone receptors and their expression 

in immune cells and the influence of hormones on

immune physiology. The thymus is known to be 

sensitive to hormone fluctuations. However, what 

is the effect of hormones on thymic selection, the

process by which T lymphocytes are positively 

selected for survival or deleted. Hormonal fluctuations may serve to alter thresholds for death, survival,

and activation of cells. It is known that cell trafficking

is markedly affected by the expression of cell surface

adhesion molecules. Research is needed on the effects

of hormones on adhesion molecule expression and 

the movement of cells. The effects of hormones on 

cells and cellular signaling is just beginning to be

understood. It is reasonable to postulate that hormones may have stimulatory or inhibitory influences

on gene expression for most cytokines. It is also reasonable to speculate that hormones will influence 

the gene expression of cytokine receptors and their

function. Hormones may also affect the composition

and stability of the extracellular matrix. In addition 

to sex steroid hormones, the influence of other hormones, including hypothalamic, pituitary, and 

adrenal, should be examined. 

Target Organs

Immune activation and response to immune 

mediators can be regulated locally with specific 

tissues differing in their ability to serve as sites of

immune activation or immune destruction. For 

example, the brain has been shown to be a site for 

considerable apoptosis (programmed cell death) 

of lymphocytes. In addition, the eye has been

described as an immune privileged site. Further 

exploration of the role of these target organs, as 

well as the thyroid, pancreas, and skin, in modulating the immune response is needed. Specifically, 

what are the differences in target organs with respect 

to activation of immune responses and response to

autoimmune attack? Equally, certain tumors have

mechanisms to evade immune destruction. What 

are the genetic, hormonal, cytokine, or other factors

regulating the differences in these tissues?

How do these factors influence the response to

implanted devices? What local factors influence the

immune response in transplanted organs. Existing 

data suggest that the sex of a kidney transplant 
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donor may be an important determinant of the 

success of engraftment. 

Tolerance and Immunologic Unresponsiveness

Tolerance can be broadly defined as a selective block in the immune response to a particular 

antigen. Tolerance can be induced by the deletion 

or specific inactivation (anergy) of antigen reactive 

lymphocytes; alteration of the cytokine milieu to 

prevent inflammation; or induction of regulatory 

T cells or cytokines to down-regulate activation 

of antigen specific T cells. This is an area with 

great importance to clinical medicine, especially 

transplantation, and the prevention and treatment 

of allergy and autoimmune diseases. 

Several areas offer particular promise. T cell 

ligands, which specifically activate (agonists) or 

inactivate (antagonists) cells, can differ by a single

amino acid. Therefore, exposure of autoreactive 

T cells to an altered peptide ligand could potentially prevent activation of those cells. Activation 

of T cells requires co-stimulation in addition to 

binding of the T cell receptor and MHC-antigen 

complex; blocking this co-stimulation prevents 

T cell activation leading to tolerance. This approach 

is being utilized in pilot trials in autoimmune 

disease and to prevent transplantation rejection. 

Much has been learned about the active suppression and deletional mechanisms operative in mucosal

(oral) tolerance. However, early trials have shown

dosage of fed-antigen is critically important. More 

trials are needed to explore antigen dose and mechanism of mucosal tolerance in humans. Several different pathways, each involving different pairs of 

molecules, have been described for activation of 

apoptosis or programmed cell death. The regulation 

of these pathways in the development of tolerance 

or autoimmune diseases is needed. The thymus is

actively involved in positive and negative selection 

in the infant and child, but becomes involuted in 

the adult. The role of the thymus in tolerance 

induction in the adult needs to be explored. 

Innate Immunity

The nonadaptive, non-antigen-specific arm 

of the immune system has recently become a focus 

of immunologic study. Mast cells, neutrophils, and

monocytes frequently contribute to the inflammation

observed with protective or pathologic immune

responses. Natural killer (NK) cells have become 

an area of active investigation. Investigators have 

only recently begun to appreciate the contributions 

of all of these cell types in the immune response to

asthma, transplant rejection, and autoimmunity. 

Complement proteins that function by cooperating

with the body’s other defense mechanisms represent 

an indispensable part of the immune response. When

activated, the complement proteins coat the surface 

of a foreign organism, flagging it for digestion by

macrophages. Scientists have long recognized the

impact of complement on immune response through

the study of individuals with complement deficiencies.

However, they have only recently begun conducting

mechanistic studies to determine the basis for the

observed immune dysregulation. More studies of 

innate immunity are required.

Clinical Investigation

More information is needed concerning the 

incidence, natural history, genetics, gender differences, and risk factors for immune mediated diseases, such as rheumatoid arthritis, multiple sclerosis, 

scleroderma, systemic lupus erythematosus, Sjögren’s

syndrome, and asthma. Easily available and reproducible assays that correlate with clinical risk, disease

activity, or response to therapy are needed for these

diseases to more accurately and more quickly test 

new therapies. Information about the response of 

men versus women in clinical trials may suggest 

gender specific therapies. An improved understanding of the appropriate assays to measure immune 

function in different diseases and at different stages 

of disease could lead to better management of 

these diseases. 
“Basic research will yield information that 

benefits the treatment and diagnosis of all 

autoimmune diseases and represents the most 

promising approach to finding a cure.”

Virginia T. Ladd, R.T.

American Autoimmune 

Related Diseases 

Association

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RESEARCH 

RECOMMENDATIONS

The following recommendations are made for

future research and to improve clinical care in areas 

of immunity and autoimmune disorders: 

• Identify resistance/susceptibility genes for 

multigenic diseases such as rheumatoid 

arthritis, systemic lupus erythematosus, 

multiple sclerosis, scleroderma, Sjögren’s 

syndrome, type 1 diabetes, and asthma.

• Identify the effects of environmental influences

such as diet, stress, allergen exposure, and 

exogenous estrogens on immune function.

• Study the comparative effects of sex and age 

on normal and abnormal immune function 

in animals and humans; determination of 

the role of stages of the menstrual cycle 

on immune function.

• Determine the effects of sex steroid hormones

(estrogens and androgens), other hormones, 

and hormone fluctuations on different aspects 

of the immune response.

• Identify the immunologic environment in the 

target organ in various autoimmune diseases — 

the brain in multiple sclerosis, the joint in 

rheumatoid arthritis, the beta cells in diabetes, 

the kidney and vasculature in systemic lupus 

erythematosus, the lung in asthma, and the 

skin in scleroderma.

• Determine successful methods to inactivate 

autoreactive immune cells in autoimmune 

disease. T cell antagonists, mucosal tolerance, 

and methods to promote lymphocyte deletion 

are likely possibilities.

• Determine the role of innate immune mechanisms in immune and allergic diseases and 

therapeutic interventions.

• Establish improved surrogate markers to 

measure disease activity and response to 

therapy in diseases such as rheumatoid 

arthritis, multiple sclerosis, scleroderma, 

systemic lupus erythematosus, and 

Sjögren’s syndrome. 

Overarching Issues

The working group agreed that the following broad recommendations should be generally

applied to all aspects of immunological research 

in women’s health.

• Researchers and clinicians should develop 

procedures for rational and wise selection 

of clinical trials, particularly in rare diseases. 

The limited number of patients with these 

diseases may limit the number of clinical 

trials that can be performed. Clinical trials 

must be designed to reflect a heightened 

sensitivity to the problems associated with 

retention of subjects from special populations

(these populations include women of color 

and women of low socioeconomic status). 

Equal representation of subjects from all 

ethnic and socioeconomic groups should 

be assured and appropriate clinical studies 

on rare diseases undertaken. There is a vital 

need to maintain access to patients under 
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managed care for clinical trials and to ensure 

that advances in clinical medicine and opportunities to participate in clinical studies 

are made available to patients in managed 

care programs.

• Achieving significant progress in these areas 

will require multidisciplinary approaches and, 

in studies of human populations, multicenter 

collaborations.2 Access to data and tissue 

repositories should be simplified while protecting patient confidentiality. Expanded interactions

between researchers, government, industry, 

and the private sector should be encouraged.

Communication and Information Access

Access to information that would be useful 

for management of patients with these diseases is 

not universally available. Access to archival information from clinical trials could enhance clinical 

care. Communication of information between 

clinical and basic investigators would facilitate 

translation of research findings into clinical practice. Increased communication between patients, 

basic scientists, and clinicians could lead to new 

areas of research.

Summary

In summary, the working group suggested 

implementation of the following recommendations for future research and strategies to improve 

clinical care in the areas of immunity and autoimmune disorders:

• Research designed to address the gaps in 

knowledge and to exploit the opportunities 

defined above.

• Design of information systems that allow 

easier access to archival material on clinical 

and genetic studies.

• Increased multidisciplinary research.

• Greater sharing of resources among researchers

(this includes sharing of clinical samples, DNA

banks, serum banks, animals, and reagents).

• Better communication between the lay public 

and the scientific community, making information readily accessible to researchers, health 

care providers, and consumers.

• Stratification of future and existing data 

from basic and clinical studies for sex and 

age of subjects.

Benefits that can be anticipated from increased

knowledge of the unique aspects of the woman’s

immune response include a better understanding 

of autoimmune disease, asthma and allergic responses,

transplant engraftment and rejection, tumor immunity,

and protection from microbial infection. This information could lead to improved therapeutic protocols

for vaccination, tolerance induction, and transplantation. Ultimately, new knowledge will permit us to 

predict how environmental factors and lifestyle will

affect the immune response and how to identify 

those individuals who are genetically at risk for

immune dysfunction. The rapid and reliable translation of such knowledge into the health care 

system, to inform the practice of both physicians 

and patients, is a goal that can be achieved with

improvement in communication. 

References

1 Office of Research on Women’s Health. Report of the

National Institutes of Health: Opportunities for Research

on Women’s Health. Hunt Valley, Md: National Institutes 

of Health, 1992. p. 195-206.

2 Office of Research on Women’s Health. Beyond Hunt 

Valley: Research on Women’s Health for the 21st Century,

Interim Proceedings of the Public Hearing and Scientific

Workshop: September 25-27, 1996. Philadelphia, Pa:

National Institutes of Health, 1997. p. 46-56.
INFECTIOUS DISEASES

AND EMERGING 

INFECTIONS

BACKGROUND

The startling advances since 1991 in the detection and treatment of infectious diseases inwomen indicate what still needs to be accomplished. The 1991 Hunt Valley report grouped together

research recommendations in immunology and infectious diseases. The current report recognizes the 

growing importance of both these areas and treats 

their discussion and research recommendations 

in separate sections.

It was not possible for this working group to 

cover all infectious diseases of particular importance 

to women. Time was, of course, a consideration; 

however, the expertise of the working group as well 

as evidence of the increasing scope of the epidemics 

led to a focus on sexually transmitted diseases (STDs)

and HIV/AIDS, with limited discussion of a significant

number of other infectious diseases. The group did 

not discuss urologic diseases of women; this subject 

is covered in a separate report. The four sections 

that follow focus on STDs and HIV, with passing 

references to other infectious diseases from which

women suffer disproportionately. Discussion within

each section of this report is divided into basic 

science, epidemiology, clinical practice, and behavior

and education.

Sexually transmitted diseases, including HIV/AIDS,

require a continued concentrated research effort. Many

of the STDs are more difficult to detect in women than

in men, and in many ways these diseases affect women

more severely. As a consequence of STDs, women 

may experience infertility, tubal pregnancy, genital 

cancer, early fetal loss, and congenital or perinatal

infection. Efforts should be continued to reveal more

about the microbial and behavioral etiology of these

infections; their differential effects on women across 

the life span; measures women can take to prevent 

contracting them or prevent their progression to 

later stages; and the effects of these diseases on 

the communities and subcommunities in which

women live.

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

Advances in Basic Science

Basic research progress in the fields of HIV 

and STDs during the past 5 years is evidenced in 

the many new studies being undertaken and in 

the significant increase over the past several years 

in research funding. The ambitious research and 

program agendas of NIH and CDC have included 

an increase in funding by the National Institute of

Allergy and Infectious Diseases of STD centers that 

are focusing on an examination of the vaginal ecosystem. Other projects have begun to characterize 

the endogenous defense systems of the vagina and

cervix. Grant-funded research is currently focusing 

on vaginal immunology and physiology, and is 

examining normal and abnormal vaginal ecosystem

responses to preventive and therapeutic agents. 

Cochairs

Sharilyn K. Stanley, M.D.

National Institute of Allergy and Infectious Diseases

National Institutes of Health 

Howard Minkoff, M.D. 

SUNY Health Science Center at Brooklyn

Rapporteur: Donna R. Savage, M.Ed.

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Examples of basic scientific progress include the 

development of single-dose azithromycin for treatment of chlamydia and research on mucosal factors 

in relation to STDs.

The medical literature has reported new advances

in basic science research on HIV/AIDS. For example,

the findings of the AIDS Clinical Trial Group 076

showed that in pregnant women with HIV, antepartum and intrapartum zidovudine (AZT) treatment 

of the mother followed by short-term treatment of 

the baby reduced the risk of vertical transmission 

of HIV infection from 25.5 percent to 8.3 percent.

Recent data suggest that when used in conjunction

with elective cesarean section, ZDV is associated 

with even lower vertical transmission rates. New 

antiviral drugs have been studied and approved 

for treatment of HIV-infected persons, including 

protease inhibitors, which are an entirely new class 

of antiviral drugs. People who elect antiviral therapy

can now take a combination regimen that results in

sustained suppression of virus production, increased

CD4 cell counts, and improved quality of life. Specifically with regard to women’s health, recent advances 

in basic research on HIV include, in addition to the

focus on perinatal transmission of the virus, research

on the natural history of the virus and its disease 

progression in women. The case definition for 

AIDS in women has been expanded to include 

new diagnostic criteria for HIV-positive persons

(including invasive cervical cancer); this has resulted 

in improved identification of previously unsuspected

HIV infection in women.

Epidemiologic Advances

Epidemiologic research has highlighted both 

the extent of the STD epidemic in the United States

and its consequences. For example, a major finding 

in recent years is the demonstration of a causal relationship between human papilloma virus (HPV) and

cervical cancer; so strong is that causal relationship 

that cervical cancer can now be considered an STD.

With the advent of urine-based testing and regulations to obligate STD reporting, epidemiologists 

revised the estimates of the magnitude of chlamydia

infections in the United States; whereas the estimate 

of American women infected annually had been 

around 4 million, that figure is now 8 to 10 million

infections per year. The estimates for Americans 

infected with genital herpes and human papilloma

virus are 43 million and 40 million, respectively.

Hepatitis C, although seemingly less often transmitted sexually, can be transmitted heterosexually 

and from mother to child, and infects approximately

1.4 percent of Americans. In addition, scientists are

beginning to identify individuals who are either 

nonprogressors or resistant to STDs despite 

exposure or infection.

One of the greatest advances in understanding 

the epidemiology of STDs and HIV is the finding 

that the diagnosis and the treatment of STDs decreases

the risk of HIV transmission. One study has demonstrated that the treatment of persons with STDs resulted in a significant reduction in the incidence of HIV

infection in the treated population. In addition, 

routine screening for asymptomatic chlamydia has

proven efficacious in reducing the incidence of 

pelvic inflammatory disease.

Natural history studies of HIV in women have

helped determine how HIV is acquired and the appropriate clinical utility and prognostic significance of 

viral load and CD4 counts. The gynecologic manifestations of HIV are also being defined. More accurate and more timely diagnoses of HIV in women 

have resulted from the broadening of the case definition for AIDS, which includes increasing the range 

of symptoms that defines the presence of HIV in

women, as well as the increasing recognition by 

clinicians that women are at risk for HIV infection. 

The risk factors for heterosexual transmission of 

HIV are now better defined.

Advances in Clinical Practice

Clinical and therapeutic triumphs of the past 

5 years are evident in the availability of new diagnostic tests and new drugs, including antiretrovirals
“. . . the need for woman-controlled methods 

of STD and HIV prevention has only recently 

been recognized as a priority, and much remains 

to be done to move this issue to the forefront 

of the women’s health agenda.”

Amy Allina

Reproductive Health 

Technologies Project

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(especially protease inhibitors). The findings of the

AIDS Clinical Trial Group 076 showed that when 

AZT was given to pregnant women during pregnancy and delivery, and to infants in the first six 

weeks of life, the risk of vertical transmission of 

HIV was reduced substantially (25.5 percent to 

8.3 percent). Short course therapy (starting at 

36 weeks of pregnancy) has also been shown to 

reduce rates of transmission. Single-dose therapies,

such as azithromycin for treatment of chlamydia, 

show great promise in large part because ongoing

patient compliance is not required. Better diagnostic methods have been developed, such as 

polymerase chain reaction (PCR) and liquid chain 

reaction techniques using urine-based (and therefore noninvasive) sampling for the diagnosis of 

chlamydia infection; multiplex PCR for congenital 

ulcer disease; and home-based tests for HIV. Other 

clinical progress includes earlier diagnosis of infections such as chlamydia and HIV that allows the 

prevention of complications of disease, and the 

development of the second-generation hepatitis B 

vaccine and the improved acellular pertussis vaccine.

Advances in Behavior and Education

Epidemiologic data have helped to describe 

the occurrences and transmission of STDs and 

have helped bring about an increased sensitivity 

to the importance of behavior as an area that 

should be studied and addressed. For example, 

documentation of the increasing numbers of 

women diagnosed with HIV has led to growing 

awareness that the HIV epidemic is not limited 

to the homosexual male population. This awareness has prompted more diverse educational 

messages about HIV resulting in significantly 

increased awareness that women may be at risk 

for HIV infection. With counseling, voluntary 

testing for HIV infection has increased. In some 

settings, condom use has increased substantially; 

the Thailand prostitute study indicated that consistent condom use can substantially reduce 

STD transmission.

Advances in Scientific Perspective

What has begun to underlie the scientific 

progress described above is progress in the conceptual perspective about research on women’s 

health. No longer is the vagina viewed, in research

terms, merely as a repository for semen and a vessel 

for fetal and/or microbial growth, but rather as a 

complex ecosystem that should be studied in this 

context in order to advance biomedical knowledge

about the infectious diseases that afflict women.

Change in Questions Since Hunt Valley

The working group observed that, in the years

since the 1991 Hunt Valley Report, a conceptual 

paradigm shift has occurred regarding research on

women’s health. Because society and the health 

professions are now less likely to view women as 

mere reproductive beings, the concept of “women’s

health” has expanded beyond reproductive health

issues; serious attention is being paid to the great 

variety of morbidity and mortality health issues 

affecting women.

The female genital tract is not simply a “receptacle” and conduit of infection or reproduction, but

rather an ecological system not yet well understood.

Complex and multiple events occur in the vaginal

ecosystem, leading to questions such as “What does 
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it mean to study the vagina?” and “How does what

happens in the vagina affect the whole woman?”

GAPS IN KNOWLEDGE

Basic Science

The consensus about the importance of a 

research focus on the vagina as an ecosystem brings 

to light a myriad of gaps in basic science: general

knowledge about the vaginal ecosystem, interactions 

of the vaginal ecology with multiple exogenous substances (topical microbicides, sperm, and douching),

effective topical microbicides that are not necessarily

spermicidal, and vaginal microbiology across the

woman’s life span. Gaps in prevention and diagnosis

include the lack of an effective procedure for diagnosing syphilis at certain stages, understanding the role 

of STDs in adverse outcomes of pregnancy, the lack 

of an effective vaccine for most STDs, and the 

unavailability of rational advice to offer on the 

management of human papilloma virus infection. 

The need identified in the 1991 Hunt Valley 

report for useful animal models still exists. Other 

gaps include understanding what happens once 

an organism invades the host and how the host 

controls or eliminates the infection; adverse neonatal outcomes related to maternal STDs, including

why herpes-infected newborns develop a wide range 

of different symptoms; and the pathogenesis of 

infertility and tubal scarring, including why some

women recover reproductive ability after pelvic 

inflammatory disease whereas others do not.

Gaps in basic science knowledge of HIV 

infection range from understanding the precise 

mechanisms of transmission to delineating the 

pathogenesis of full-blown AIDS in women. Gaps 

in knowledge about transmission and initial infection include how to quantitate the infectious viral 

load in genital secretions, how infection is established (what is the first cell that gets infected?), 

the in vivo role of peptides that inactivate HIV 

and other organisms and viruses in test tubes, 

and the effectiveness of natural defense mechanisms such as pH level and the presence of lactobacilli. Gaps in knowledge about HIV, pregnancy, 

and hormones include the role of the placenta 

as a viral barrier (75 percent of infants born to 

an infected mother are not themselves infected);

whether pregnancy increases susceptibility to 

HIV infection; the role of HIV in adverse outcomes 

of pregnancy; hormonal influences on viral expression; and the safety of antiretroviral drug treatment

during pregnancy. Additional gaps include the 

biologic interaction of STDs and HIV, particularly

regarding effects on the regulation of HIV expression, oral markers for HIV infection, vaginal 

yeast infections as early markers, and HIV strain 

differences regarding susceptibility to and progression of infection.

Epidemiology

Gaps in epidemiologic knowledge of STDs and

HIV include the need to readdress the conditions 

that should be reportable as an STD and the legal 

and ethical barriers to reporting. Barriers exist to

enrolling women in natural history studies, especially

in the use of consent forms and conforming to study

guidelines. Research is sorely lacking on women in

medically underserved communities such as correctional facilities, where rates of STD and HIV infection

are very high. There is a paucity of data on STDs 

in sexually abused children and adults. Long-term 

epidemiologic studies on STDs are needed; for 

example, research to evaluate the long-term outcome in babies who were given AZT for 6 weeks 

after birth to prevent HIV vertical transmission 

from the mothers.

Structural methods are needed to design 

community-based studies and to evaluate this 

data in a manner that leads to valid conclusions. 

These studies would focus on risk factors that 

occur on a community-wide level, including 

sociocultural factors.
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Research should also be conducted to better 

define the transmission and epidemiology of herpes

simplex virus; to determine the optimal timing for

administration of the hepatitis B virus vaccine and 

the length of time its protective effect will persist; 

to understand chlamydial disease progression and 

the development of complications; to describe the 

natural history of Trichimonas vaginalis (T. vag.) 

infection in men as asymptomatic transmitters to

women; to define, using population-based studies, 

the role of lacto-bacillus and other normal vaginal 

flora in preventing infection; and to understand 

better the findings of previous surveys that indicate

that gonorrhea, syphilis, and HIV infection all overlap within the same population. Research is also 

needed to understand the natural history of human

papilloma virus. A greater understanding of the 

contribution of heterosexual activity to the spread 

of hepatitis C is needed. Epidemiologic studies 

focusing on the serotypes of HIV and the relationship of these serotypes to mechanisms of HIV 

transmission and course of disease are needed. 

Finally, more powerful microbiologic tools are 

needed to facilitate epidemiologic research.

Clinical Practice

Despite progress since the 1991 Hunt Valley

report, women are still not being sufficiently enrolled

in clinical trials. This is true particularly for underserved women such as substance abusers or women

who are incarcerated. In some prisons, women are

screened for infectious diseases and are isolated if

infected, while in other prisons this does not occur. 

For a variety of reasons, women who are incarcerated

or who are drug abusers also do not have access to 

the latest treatments for infectious diseases. The failure to screen and treat incarcerated women not only

presents a health concern inside prison walls but 

also creates a serious public health issue in the community, since most of the incarcerated women will

return to the general population. 

Clinical practice still does not have inexpensive,

rapid, noninvasive, reliable diagnostic methods and

vaccines for viral STDs, including HIV. Other 

clinical concerns include the increasing microbial 

resistance to therapies, the diagnosis and treatment 

of tertiary syphilis, methods for the complete elimination of chlamydia infection and subsequent prevention of tubal scarring, and the development of 

single-dose therapies for infections other than chlamydia. Significant gaps also exist in our understanding 

of the acceptance of, compliance with, and optimal

immunologic timing and techniques for STD vaccination protocols; the immunologic consequences of 

such vaccines are also not currently understood.

Two additional factors may have contributed 

to the continued gaps in the laboratory diagnosis 

of STDs. First, the well-intentioned requirement of 

the CDC-issued Clinical Laboratory Improvement 

Act (CLIA) that mandates that clinics that routinely

perform STD tests obtain special certification may 

have had the unexpected result of a decline in laboratory testing for STDs. Second, the emergence of managed care will almost certainly impact STD screening

and may result in a decrease in prevention and screening. An emphasis on the cost effectiveness of prevention and screening over the treatment of established

infection will be necessary to avoid a reduction in 

the availability and utilization of these services.

More information is needed about the effects 

of therapy for STDs and HIV on pregnancy. Finally,

optimal methods for the prevention of perinatal 

infections remain an area for further investigation.

Behavior and Education

Fundamental knowledge and research are 

lacking on the conduct of patients and health care

providers. For instance, given that messages from

physicians have been shown to make a behavioral 

difference, we still do not understand how to successfully motivate providers to discuss behavior 

with their patients.

Knowledge about sexual behaviors is also 

inadequate, particularly with regard to adolescent

behavior. The complex issues surrounding choices
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about reproductive health are not understood. For

example, what are the behavioral outcomes related 

to the competing choices of birth control versus 

STD control? How can women effectively negotiate 

for safer sex and for risk-reducing behavior in their

steady or casual consorts? Recent experience with 

multidrug therapy and the development of resistance

has highlighted the need for greater understanding 

of the determinants of adherence.

RESEARCH 

RECOMMENDATIONS

Crosscutting Themes

To direct and develop the research questions 

and recommendations, the working group identified

three crosscutting themes: emphasis on prevention;

recognition of the changing parameters throughout 

the woman’s life span; and understanding the continuum of health issues that ranges from the individual to

the community. These themes are defined below and

should be applied as a filter for all the recommendations for research on women’s health.

1. Emphasize prevention. Research should focus 

on a continuum of prevention methods to 

avoid infections and their complications:

• Primary: prevention of infection;

• Secondary: prevention of disease; and

• Tertiary: prevention of disease complications.

2. Consider the changing context throughout women’s 

life cycle. Research on women’s health should 

take into account the full biological life cycle 

of the woman and the concomitant physical, 

mental, and emotional changes that occur. 

Easily identifiable stages in a woman’s life are

childhood, puberty, age of reproduction, and

menopause. For example, research should elucidate the impact of the given life stage of the individual on the progression of infectious disease

from exposure to asymptomatic carriage to 

full-blown disease. In addition, there may 

be significant differences in the acceptance 

and efficacy of vaccines and therapy due to 

the effects of hormonal variations that occur

throughout the menstrual cycle.

3. Address the full continuum from the health of the 

individual to the health of the community. Research

studies should be undertaken that will affect not

only an individual woman’s health but also the

health of her family and the communities within

which the woman lives and works. Different 

infectious diseases impact certain communities to varying degrees; the reasons for this, 

and the influence of community on the diagnosis and treatment of the individual, must 

be better understood.

Basic Science

The Vagina. STD research should focus on the

human vagina. Research is needed to increase knowledge about the vaginal ecosystem: the “normal” state,

alterations caused or enhanced by exogenous factors;

effects of the menstrual cycle on disease; effects of the

frequency of intercourse, both with single and with

multiple partners, on disease; and changes in the 

vaginal ecosystem across the life span.

Primary Prevention Tools. Research should 

focus on the effectiveness of exogenous hormones, 

topical microbicides, barrier methods, and vaccines 

as primary prevention of STDs, including HIV. The

development of nonspermicidal microbicides is necessary for women who want to prevent infectious disease

but not necessarily pregnancy. An important public

perception for researchers to consider is that, when 

the individual feels protected against pregnancy and/

or against one STD because of the use of a barrier

method, they also incorrectly feel protected against 

all STDs. For example, a condom does not protect 

the individual from contracting chlamydia or human

papilloma virus; nevertheless, the public perceives 

condoms as protection against all STDs. This must 

be considered in STD primary prevention research. 
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Pathogenesis of STDs. Research on the 

pathogenesis of STDs should focus on the requirements for microbial growth, survival, and reproduction, and on environmental factors that enhance 

microbial growth; on determining whether genetic 

predispositions render certain hosts more or less 

susceptible to microbes; and on how the status 

of the host’s immune system affects microbial 

growth and reproduction. Thus, research must 

address microbial, host-genetic, and host-immunologic factors. Research to investigate the 

interactions within the host between STDs 

and HIV is needed.

Basic Pathogenesis of HIV. Research to 

elucidate the pathogenesis of HIV/AIDS in women

should be continued and include the study of the 

influences of hormonal and other natural defenses 

on viral expression, the local vaginal factors that 

affect susceptibility and disease progression, and 

mechanisms of vertical transmission. 

Therapeutics for Adverse Outcomes of 

Pregnancy. Continue and increase research to 

prevent the myriad of adverse outcomes of pregnancy caused by STDs and HIV. Conduct research 

on infertility, its causes, and methods to reverse it.

Hormonal Birth Control Methods. A systematic research agenda is needed for the study 

of the potential effects of hormonal birth control 

methods on a woman’s susceptibility to infection. 

Such research must include girls and women 

across a wide range of reproductive ages. A safe,

female-controlled contraceptive method that 

would be effective in preventing pregnancy and 

the transmission of STDs, including HIV, should 

be developed. In this regard, studies are needed 

on the efficacy of the female condom for contraception and prevention of STDs.

Animal or Other Reproductive Models for 

Effective Study of STDs. While important, the 

development of animal models should not be undertaken at the expense of research devoted to women.

Caveats for using animal models include the substantial differences between the mechanisms of 

action of hormones and microbes in humans versus

other species, and the differences in frequency of 

sexual contact and number of sexual partners.

Epidemiology

Follow-up Studies. Follow-up studies should 

be conducted to determine the long-term sequelae 

of vaccines, treatments, and disease progression. 

For example, babies who were given AZT in utero 

and during their first 6 weeks of life to prevent 

vertical transmission of HIV are being followed, 

with particular emphasis on identifying potential 

late adverse effects of AZT. A few additional longterm epidemiologic studies exist for HIV, but very 

few exist for other STDs. Gonorrhea, syphilis, and 

HIV overlap significantly in some populations; 

followup studies should be done with these 

populations as well.

Community-based Studies. Risk behavior 

and risk factors for STDs, including HIV, that 

occur on a community-wide level need to be 

identified. Methods to design community interventions and evaluate the resulting data can then 

be developed.

Link Between Race and Disease. Conduct

research to determine whether a relationship exists

between race-based factors and specific infectious 

diseases. For example, gonorrhea is 60 times more

prevalent in blacks than in whites; this could result

from several different factors, such as genetic susceptibility or community behaviors. Understanding 

the reasons is essential to the development of effective prevention and treatment. Factors that may 

be implicated in disease progression and infection

include genetic, environmental, socioeconomic, 

and sociocultural factors.

Access to Underserved Groups. Research 

should be conducted on populations with high 

rates of infectious diseases, which have typically 
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been understudied or underaccessed. For example,

STD/HIV rates in prisons are very high, and epidemiologic research on this population is sorely lacking.

Natural History of T. Vag. in Men. Conduct

research to determine the role of men as reservoirs 

for T. vag. and as asymptomatic transmitters of the 

disease to women.

HIV Serotypes. Conduct epidemiologic studies 

to provide data on the effect of HIV serotypes on HIV

transmission and development of disease. Delineate 

the factors that contribute to differences in virulence 

as well as differences in regional transmission of 

certain serotypes.

Microbiologic Tools. Develop microbiologic 

tools to facilitate epidemiologic research. 

Clinical Practice

Product Development. The phrase “diagnose

everything easily and cure everything simply” sums 

up the long-term recommendation for product development. New diagnostic methods and treatments

should be inexpensive, rapid-acting, as noninvasive as possible, reliable, accurate, and easy to 

use; product research should make these characteristics a priority.

Clinical Trials. Enroll more women in efficacy 

and safety trials. This recommendation has two implications: (1) conduct more clinical trials on women’s

health issues and (2) enroll more women in clinical 

trials in which men have previously prevailed in 

numbers. Specifically, clinical trials on microbicides

and other barrier methods are needed to define the 

efficacy, the safety, and the long-term sequelae of 

STD and HIV therapy not only on the “typical” 

patient but also on pregnancy and neonatal outcome. Researchers will need access to clinical trials 

and treatment for women with HIV and women 

who are pregnant; both groups have often been 

excluded from studies in the past. In addition, 

studies should be conducted on patients with 

multiple infections.

Cures and Vaccines. Continue research to 

find cures for viral STDs and HIV, to develop 

methods to combat microbial resistance, and to 

develop treatments and vaccines to prevent or 

eradicate these infections entirely. Train dental 

personnel to recognize oral lesions as a sign of 

HIV infection.

Public Health Policy Research. Evaluate ways 

to reduce the negative consequences of changes in

public health policies. Begin to think about how to

implement nationwide vaccine-delivery programs, 

patterned perhaps on the delivery of the measles 

vaccine, so that the medical establishment is prepared for the upcoming completion of the herpes 

simplex vaccine as the first in what will hopefully 

be a series of vaccines for STDs.

Prevention and Treatment for Underserved

Women. Study the consequences of inadequate 

comprehensive prevention and therapy for STDs/

HIV in prisons. Study the impact of needle 

exchange programs on the spread of HIV.

Behavior and Education

Behavioral Methodologies and Measurement.

Conduct behavioral science research on both patients

and health care providers. For behavioral theories that

already exist, determine if they are being validated and

used effectively to alter behavior. For new theories that

may be formulated, provide access for utilization and

validation in the field.

Sexual Behaviors, Especially of Adolescents.

Develop a catalog of sexual behaviors as a base for any

intervention strategy. This recommendation underpins

many of the other research recommendations in this

report. The development of effective vaccines, cures,

and prevention messages relies on an understanding 

of sexual behavior across the life span and within and

across communities.

Subject Participation and Compliance. 

Conduct research on how to increase recruitment 

and retention in clinical trials and how to enhance
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compliance with treatment regimens. If treatment 

compliance research results in only a 10 percent

increase in compliance, this will indicate a substantial need for improvement in screening, prenatal 

care, vaccinations, condom use, microbicide use, 

and other prevention methods. There should be 

a focus on pregnant women and women who use 

illegal drugs, since compliance issues are often 

of particular concern within these groups.

Effects of Public Health Messages and Societal

Norms on Behavior. Information is necessary, but 

not sufficient, for behavior change. Research is needed

to determine not only what information should be disseminated but also how information is delivered. For

example, most people know that HIV is fatal, but this

information often does not change risk-taking behaviors. Public health messages must be evaluated with 

the understanding that societal beliefs and social 

norms are essential components of behavior change.

Evaluation of public health campaigns should consider the behavioral outcomes of the competing 

choices women must make; for instance, a choice 

to prevent STDs but not necessarily to prevent 

pregnancy. Research on the impact of popular culture and societal norms on individual and group

behavior change is crucial.

Other Research Recommendations

In addition to STDs and HIV, many other 

women’s health issues related to infectious diseases

should receive research attention in the next 5 years.

The working group did not have the time or the 

expertise to deal with these issues in depth but

believed they should be addressed in this report. 

These issues include the following:

Urinary Tract Infections. Morbidity associated

with urinary tract infections encompasses such problems as “honeymoon cystitis” and incontinence.

Tuberculosis. After adolescence, a woman’s 

risk of disease progression after exposure to tuberculosis is significantly higher than a man’s risk. 

An understanding of the factors contributing to 

this increased susceptibility to disease, such as 

hormones, pregnancy, contraceptives, or lifestyle, 

is needed.

Chlamydia and Heart Disease. More women 

die from heart disease than from breast cancer. With

recent findings that chlamydia may be involved in 

atherosclerotic lesions, this relationship in women 

must be evaluated.

Chronic Fatigue Syndrome. Investigators are 

currently searching for an infectious disease cause 

for chronic fatigue syndrome, a condition that affects

women twice as often as men. Further research into 

the pathophysiology of this condition is warranted.

Malaria. Initial research indicates that pregnancy increases the death rate from malaria and 

that the disease has an affinity for certain placental

cells. More research is needed on this reemerging 

infectious disease.

Group B Strep. This infection is the number 

one cause of neonatal septicemia. With additional

research, particularly vaccine development, this 

disease could be diagnosed, treated, and eliminated.

Other Infectious Diseases. Other infectious 

disease issues for women’s health research include 

bacterial vaginosis and other nonsexually transmitted

vaginal diseases, hepatitis C, H. pylori, infectious 

etiologies of rheumatoid diseases, toxic shock syndrome, and the long-term immunologic sequelae 

of rubella vaccinations.

Emerging Infections. Emerging infections 

are infections that either have newly appeared,

appeared in species previously unaffected, or are 

rapidly increasing in incidence or geographic range.

Recent examples include outbreaks of plague in 

Surat and India and the Ebola virus infection in 

Zaire. Most emerging infections are not caused 

by genuinely new pathogens. Shifting ecological, 

environmental, and demographic factors precipitate 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

the emergence of disease either by placing nonimmune people in increased contact with a pathogen 

or its natural host in its native environment, or by 

promoting dissemination into new regions or new

hosts. The current volume, speed, and reach of international travel make emerging infections a significant

global problem. The working group made specific 

note of the importance of cooperative research and

information sharing with other countries.

Recommendation for Developing a Full Agenda

The working group recommends that a 2-day

retreat be arranged to delve more fully into the 

diseases listed. Infectious diseases are critical health

issues for women, and a longer period of time is 

needed to develop a full agenda for women’s 

health research in infectious diseases.

References

Brown ZA, Berry S, Vontver LA. Genital herpes simplex virus

infections complicating pregnancy. Natural history and peripartum management. J Reprod Med 1986;31(5 Suppl):420-425.

Eng TR, Butler WT, editors. The hidden epidemic: confronting

sexually transmitted diseases. (Institute of Medicine) National

Academy Press; 1997.

Ho GY, Bierman R, Beardsley L, Chang CJ, Burk RD. Natural

history of cervicovaginal papillomavirus infection in young

women. N Engl J Med 1998;338(7):423-428.

Holmberg SD. The estimated prevalence and incidence of 

HIV in 96 large US metropolitan areas. Am J Public Health

1996 May;86(5):642-54.

Perelson AS, Neumann AU, Markowitz M, Leonard JM, Ho DD.

HIV-1 dynamics in vivo: virion clearance rate, infected cell lifespan, and viral generation time. Science 1996;271:1582-1586.

Quinn TC. Global burden of the HIV pandemic. Lancet 1996;

348(9020):99-106.

Rosenberg PS. Scope of the AIDS epidemic in the United 

States. Science 1995;270(5240):1372-75.
MENTAL DISORDERS

BACKGROUND

Although mental disorders were not a formal

topic for discussion at the 1991 Hunt Valley

conference, the mental health problems of

women were noted. The integration of the National

Institute of Mental Health into NIH has given mental

disorders equal status with physical diseases, disorders,

and conditions.

Gender-related biological and psychosocial factors 

are recognized as important factors in the etiology,

cause, and treatment of mental disorders. With new

awareness about the ways in which the differences

between women and men affect both physical and

mental health, it is critical to present, study, evaluate,

and implement changes derived from gender-based

research to positively influence the treatment of 

mental disorders in women. Concerns about mental

disorders must be addressed through a multitiered

approach with clinicians and researchers willing and

able to work even more closely together to promote

mental health for women in the 21st century.

The major mental disorders affect women and men 

to almost the same extent; certain disorders, however, are more likely to affect women than men. 

Major depression and dysthymia, for example, affect

approximately twice as many women as men; thus 

an estimated 6 percent of U.S. women, in contrast to 

3 percent of men, will experience a major depression

during their lifetime. Another 6 percent of women 

have dysthymia, a less severe but often more chronic

form of depression. Depression has been likened 

to an invisible plague spreading around the world — 

a disease that saps the productivity of people, distresses sufferers and their families, and adds greatly 

to a nation’s health care costs. This description was

strengthened by the worldwide Global Burden of 

Disease study conducted by the World Health 

Organization, the World Bank, and Harvard University, which found that unipolar depression ranked

fourth in magnitude of disease burden (measured in

disability-adjusted life years, or lost years of healthy

life) in 1990. The study projected that this form of

depression will continue to increase such that its 

burden will rank second only to that of ischemic 

heart disease by the year 2020.1

Another form of depression, manic-depressive 

illness (bipolar disorder) contributes an additional 

sizable disease burden. On an individual basis, 

depression ranges from severe, long-term, lifethreatening forms to milder forms of shorter 

duration. An estimated 18.4 million people in 

the United States suffer from some form of depression each year and another 2.3 million from manicdepressive illness. More than 2.1 million people 

experience the most severe forms of depressive 

disorders. Severe depression may result in sustained

productivity loss in the workplace and impairment 

in quality of life.2 Research is showing that depression also may lead to other serious physical illnesses such as heart attacks and osteoporosis.

Cochairs

Delores L. Parron, Ph.D.

National Institute of Mental Health

National Institutes of Health 

M. Katherine Shear, M.D.

Western Psychiatric Institute and Clinic

Rapporteur: Donna R. Savage, M.Ed.

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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Anxiety disorders also predominate in women, 

affecting approximately two to three times as many

women as men. The eating disorders anorexia nervosa and bulimia nervosa, conditions that may be 

related to obsessive compulsive behavior, occur 8 

to 10 times more frequently in women than men.

Anorexia and bulimia together affect 0.5 to 2 percent of adolescent girls and young women, and the

prevalence of both is increasing. Like the affective 

disorders, these anxiety disorders can become lifethreatening, even lethal; recovery is slow and relapse 

is common. Schizophrenia and manic depression 

also appear to be marked by gender differences in 

age of onset, pattern of symptoms, treatment response,

and natural course; there is no gender difference in

prevalence, however.

Mental disorders in women are inextricably linked 

to their own physical health and to the health and 

well being of their families. Because women are often

care givers for their parents and children concurrently,

mental disorders in women may affect two or three

generations. Conversely, the burdens of women’s 

multiple responsibilities often create stresses that 

can amplify mental disorders.

Simply studying a group termed “women” is not

enough. Multiple variables, in addition to gender, 

affect research and treatment: age, physical health, 

ethnicity and race, marital status, parental status, 

education, income, occupation, sexual orientation,

labor force participation, and geographic location. 

For example, women are affected by different illnesses depending on their age.

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

Recommendations from 1991 Hunt Valley Report

In the 1991 Hunt Valley Report, the working

groups recommended attention to the following 

issues related to research on mental disorders 

in women:

• Comorbidity among mental illness, substance 

use, and physical illness; identification of certain

subgroups of women at risk (genetically, by psychosocial history, chronic stress) for comorbid 

illness could prove useful for preventive treatment efforts.

• Genetic and environmental factors contributing 

to mental illness, which can guide development 

of promising prevention strategies.

• Significant gender differences in prevalence 

of mood, anxiety, and personality disorder.

• Biological and psychosocial gender-related 

variables important in the development, onset,

course, treatment, and relapse of mental disorders, including early developmental history 

and role of sexual and physical abuse.

• Gender differences in cognitive and/or 

personality variables that may influence 

onset or recurrence of disorders.

• Psychological and biological factors linked 

to gender in suicidal behaviors across the 

life span.

• Gender differences in grief reactions and 

depression following bereavement.

• Gender differences in the development of 

phobic avoidance for social and specific 

phobias and agoraphobia.

Since the establishment of ORWH there 

has been considerable progress.

Mental Disorders in Women — Progress

The latest data from epidemiological studies 

continue to show that depression, anxiety disorders,

and eating disorders affect women more often than

men. The recent National Comorbidity Study also

showed that women are more likely to have more 

than two disorders. Some progress has been made 

in the search for causes of gender-based disparity, 

and investigators are generating novel hypotheses 
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that are now propelling research forward. For 

example, preliminary data raise the possibility that

estrogen’s interactions with the circadian pacemaker

may somehow be involved in seasonal affective disorder and rapid-cycling bipolar disorder, illnesses 

that affect women more than men.3

There is much to learn about mental disorders by studying gender differences in the biology,

behavior, epidemiology, and treatment of these illnesses. The past decade has seen research flourish

along these lines, and out of that effort has come 

a new understanding of the burden that mental disorders place on women. Research targeted specifically on women’s mental health problems, including

those resulting from violence, is necessary to help

women reach their full potential — and society to 

reap the benefits of healthy women’s full participation.

Research on gender differences in mental illnesses is shedding light on the roles and interactions 

of biological and environmental factors in the following disorders.

Depression and Related Disorders. Major

depression, the most common affective disorder, is

found twice as often among women as men, a ratio

established at or before puberty (Figure 1). Women 

are more likely to have unipolar depression and

depressive (rather than manic) episodes of bipolar

(manic-depressive) illness. They also are more likely 

to have cyclical forms of mood disorders, including

rapid-cycling bipolar illness and seasonal affective 

disorder. Furthermore, women are vulnerable to 

developing depressive episodes during times of 

natural or induced reproductive hormonal change 

(i.e., during puberty, while using oral contraceptives,

premenstrually, postpartum, and during menopause).

Comparative analysis of empirical studies of mental

disorder worldwide reveals a consistency across societies and social contexts. Symptoms of depression 

and anxiety as well as unspecified psychiatric disorder

FIGURE 1. Proportion of adults with 1-year prevalence of depression: United States, 1981-85, and 1990-92.

Sources: Epidemiologic Catchment Area Study, 1981-85. Comorbidity Survey, 1990-92. National Institute of Mental Health, National Institutes of Health.

0

2

4

6

8

10

12

14

16

ALL PERSONS FEMALE

1981-85

1990-92

10.9 11.1

14.2

13.1
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and psychological distress are more prevalent among

women, whereas substance disorders are more prevalent among men. The Global Burden of Disease data

reflect these differences (Figure 2). Depressive disorder accounts for close to 30 percent of the disability

from neuropsychiatric disorders among women, but

only 12.6 percent of that among men. Conversely, 

alcohol and drug dependence accounts for 31 percent of neuropsychiatric disability among men, but

accounts for only 7 percent of the disability among

women.4 Weissman and Olfson5 affirm the finding 

that epidemiologic data from around the world 

demonstrate that major depression is approximately

twice as common in women as in men and is associated with substantial work and family impairment 

and high health care expenditures. Despite the 

robustness of this finding, little is known about 

specific etiologic factors that underlie this association. Clearly, gender is a proxy term for a system 

of psychosocial and biological variables. Further 

complexity stems from the reality that the mood 

disorders represent a broad spectrum ranging from

those that arise primarily in reaction to environmental stressors to those related more strongly to

endogenous factors. The role and relative weight 

of various gender-specific factors may differ across 

this spectrum and may also influence symptom 

patterns, comorbidity, course, treatment response, 

and outcome.

Many researchers assume that gender differences 

in the rates of depression have their root in adolescence primarily because that is when gender differences first appear. There is, however, some evidence

from recent psychosocial studies suggesting that 

factors operating in childhood may set the stage for

hormonal and neurobiological changes that occur 

in adolescence.6 A longitudinal study of social development in young children found evidence supporting

the idea that girls as young as age 4 have lower scores

than boys on measures of perceived competence, self

confidence, and self esteem and have more negative

feelings following failure. These scores correlated 

with higher scores (more depressed feelings) on 

the Children’s Depression Inventory. Scores on the

depression inventory move toward normal as the girls

proceed through the first 4 years of school, suggesting that girls are more vulnerable during periods of 

transition — entering school and entering puberty —

than during times of stability. These observations of

important developmental markers encourage consideration of interventions to help at-risk girls and women

through transition periods and thus reduce their 

vulnerability for depression.7

It is not widely appreciated that most affective 

disorders can be treated successfully. For example,

under optimal treatment with the drug lithium, 

people with bipolar illness live an average of 7 years

longer than those not receiving treatment, and they

experience 9 to 10 years of more normal health and

effective functioning, years that would otherwise 

have been lost to the illness. Nearly 85 percent of 

people with unipolar depression and dysthymia

respond positively to treatment with antidepressant medication, modern electroconvulsive therapy

(ECT), or psychotherapy, alone or in combination.

Approximately 10 percent of pregnant women

become depressed during pregnancy. In addition to

predicting postnatal depression, antepartum depression may place women at risk for anorexia and substance abuse (e.g., alcohol, drugs, and nicotine) 

and may inhibit their ability to obtain prenatal care. 

A woman’s depression at this critical time also may

have long-term effects on her newborn; infants of

depressed mothers have been shown to exhibit 

behavioral changes and irritability. Despite the potential impact of antepartum depression, clinicians are

hesitant to prescribe antidepressant medications for

pregnant women because of concerns that the medications could harm the fetus. As an alternative to 

medications, an NIMH-supported researcher evaluated the efficacy of interpersonal psychotherapy 

(for up to 16 weeks) as treatment for a multicultural

group of medically healthy pregnant women with

depression. This group of black, Hispanic, and 

white women was significantly less depressed after 

psychotherapeutic treatment — and the effects lasted 

for at least 3 months after delivery — providing initial
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FIGURE 2. Mental health problems of females and males: Worldwide percentage of DALYs* lost. (*DALY - Disability Adjusted Life Year)

Source: Adapted from the World Bank, 1993, in Desjarlais et al. World Mental Health 1995.

FEMALES

Alcohol

Dependence

3% Alzheimer/

Dementia

15%

Depressive

25%

Drug 

Dependence

3%

Epilepsy

9%

Other

17%

Psychoses

7%

PTSD

7%

Self-inflicted

Injury

14%

MALES

Alcohol

Dependence

18%

Alzheimer/

Dementia

11%

Depressive

10%

Drug 

Dependence

7% Epilepsy

10%

Other

16%

Psychoses

7%

PTSD

3%

Self-inflicted

Injury

18%
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evidence that depression during pregnancy may be 

successfully treated without medication.

Clinical depression can have a compounding 

deleterious effect on a person’s general health. A 

study funded by NIMH prospectively examined

whether a major depressive episode increases the 

risk of myocardial infarction. A large group of people

(1,551) who had taken part in a study in the early

1980s documenting depression in the general population were contacted again in the mid-1990s. People

who had been diagnosed with a major depressive

episode in the 1980s were found to have a fourfold

increased chance of having a heart attack in the intervening years. The data were statistically adjusted to

account for factors such as age, sex, smoking, marital status, and history of high blood pressure, all 

of which can affect heart attack risk. This study is

unique because, rather than examining depression 

in people who had already suffered a heart attack, 

the researchers determined the presence of depression years before the heart attacks occurred.8

Anxiety Disorders. In the term “anxiety 

disorders,” anxiety refers to several conditions: 

a disabling feeling of panic, a constant sense of 

apprehension, a phobia, or unrelenting worry 

about normal life situations. Anxiety disorders rank 

as the most prevalent forms of mental illness in the

United States, affecting more than 20 million Americans. NIMH-supported research has focused on four 

of the most serious anxiety disorders: panic disorder,

posttraumatic stress disorder (PTSD), obsessive 

compulsive disorder (OCD), and phobias. Fortunately, new, effective therapies can provide significant

relief for most of them.

Phobias and Posttraumatic Stress Disorder. 

Panic disorder occurs about twice as often in women 

as in men, and there is evidence that panic disorder 

is affected by reproductive function, including premenstrual and postpartum exacerbation and possibly some decrease in symptoms during pregnancy. 

Phobias, a type of anxiety disorder, are extremely 

common in the general population. Two to three 

times as many women as men are affected by phobias, making research on these disorders a particularly important issue for women’s mental health. 

Prevalence of agoraphobia is about four times greater 

in women than men. Data suggest that even simple

phobias predispose to more serious anxiety and 

depressive disorder in late life.

PTSD is an anxiety disorder first characterized 

in male combat veterans but soon found to affect

female victims of trauma as well. Core symptoms 

of PTSD include:

• Experiencing a distressing event that involved 

actual or threatened death or serious injury, 

or a threat to one’s physical integrity, and that

involved intense fear, helplessness, or horror;

• Re-experiencing the trauma in nightmares, 

intrusive thoughts, or flashbacks;

• Numbing of responsiveness or avoidance 

of thoughts or acts related to the trauma; and

• Symptoms of dysphoria and arousal.

Rape remains a significant problem for women, 

as does exposure to domestic violence. Overall, exposure-based interventions for rape-related PTSD, with

single or multiple treatment components, have been

found to produce a decrease or remission of posttrauma problems compared with no treatment. 

Exposure treatment, in which the victim mentally

relives the trauma, permits full processing of the 

traumatic event and reduces PTSD symptoms. Few

women receive such therapy, however; the most 

common professional intervention for rape victims 

is the limited crisis intervention counseling offered 

in rape crisis centers. Recent data show that such 

limited therapy is not enough to help many women

overcome PTSD following sexual assault, suggesting

that the nation’s rape counseling network can be significantly enhanced. There has been little study of 

psychological sequelae and treatment of victims of

domestic violence.
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Studies of women victims of violent crimes 

have shown that cognitive-behavioral interventions 

can reduce post-trauma problems that plague these

women and relieve anxiety and depression that can

limit their daily activities. Unfortunately, few women

receive such therapy. This points out the need to

increase outreach and educational efforts aimed 

at women and women’s health centers.9

Obsessive-Compulsive Disorder. Obsession 

is characterized by recurrent and unwanted thoughts,

images, or ideas that are experienced as intrusive and

senseless and compulsion by ritualized, repetitive, 

and purposeful actions perceived as unnecessary. 

The Epidemiologic Catchment Area (ECA) study

revealed that during a 1-year period, 2.1 percent 

of the adult U.S. population, or nearly 4 million 

Americans, met diagnostic criteria for OCD.

Observations of OCD symptoms, combined 

with information about brain function from imaging and surgery, point to a specific area of the brain 

— the caudate nucleus — as the source of OCD. 

The caudate nucleus is a part of the basal ganglia, 

a section of the brain believed to be involved in a 

variety of functions, including memory, sensory 

activities, and motor control. The involvement of 

the caudate nucleus in OCD was revealed by positron emission tomography (PET) scanning, which

showed that the metabolic activity of the caudate

decreases after short-term behavior therapy. In most

patients who receive the combination of exposure 

and response prevention, symptoms improve significantly, and this improvement persists over time.

Research suggests that behavior therapy might 

modify or interrupt the pathological brain circuit 

driving the patient’s OCD behavior.

A similar decrease in caudate activity occurs 

when patients are given medications that are selective serotonin reuptake inhibitors (SSRIs), such as

Prozac, which are proving effective in alleviating 

the symptoms of OCD. Investigators are also using

these drugs to probe the neurochemical and neuroanatomical origins of this disorder. Behavioral

research is leading to treatments for anxiety disorders

as well. For example, cognitive-behavioral therapies

have proven effective in helping patients identify and

change the feelings that lead to panic attacks and in

correcting the adverse consequences such as agoraphobia. The benefits of at least one of these behavioral

therapies appear to be long-lasting. Cognitive-behavioral therapies are also proving effective in alleviating

the symptoms of generalized anxiety disorder.

Eating Disorders. The eating disorders anorexia

nervosa and bulimia nervosa can be viewed as women’s

disorders because they occur 8 to 10 times more frequently in women than in men. People with anorexia

starve themselves into extreme weight loss. They have 

a severely disturbed body image, frequently viewing

themselves as fat despite being bone thin, and they

irrationally fear gaining weight. Women with bulimia

engage in frequent episodes of binge-eating followed 

by various purging behaviors such as self-induced

vomiting, fasting, excessive use of laxatives and/or

diuretics, and excessive exercise. About half of those

with anorexia develop bulimia, and many bulimics 

display anorexia-like symptoms.

To better understand the course and outcomes 

of eating disorders, NIMH is supporting a longitudinal study of anorexia and bulimia nervosa that is 

now in its ninth year. A large group of women with

these disorders are being interviewed at 6-month 

intervals. Most of the women have other mental disorders along with the eating disorders; the majority 

had a current major depression as well as at least 

one anxiety disorder when first seen by clinicians. 

The women participated in a variety of treatments, 

primarily individual therapy, but also group therapy,

family therapy, pharmacotherapy, and nutritional 

counseling. At this point in the study, indications 

are that, with appropriate therapy, a majority of

patients can recover partially or in full. This study 

is providing valuable knowledge of comorbidity 

and outcomes in anorexia and bulimia nervosa, 

knowledge that not only helps to unravel the largely

unknown origins and nature of these disorders but 

also has practical clinical applications for treatment.10
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This knowledge is also urgently needed as a base 

from which to develop appropriate educational 

efforts. A recent effort by independent educators 

to disseminate information about eating disorders 

demonstrated this need for knowledge. The educational effort had a reverse effect when the target 

audience of college girls viewed some of their colleagues describing their own experiences with 

eating disorders. At followup, the girls had slightly

more symptoms of eating disorders than controls, 

suggesting that the educational program may have 

reduced the stigma associated with these disorders 

and may have inadvertently normalized them.11

Bulimia nervosa, a serious medical condition,

affects women primarily, causing them to repeatedly binge-eat and then vomit or engage in other 

compensatory activities to avoid weight gain. Antidepressant medications and some forms of psychotherapy can be effective treatments, but they do 

not work for all patients. Research funded by 

NIMH examined both psychotherapy and medication treatments, demonstrating that both together 

are more effective than either alone, but only if the 

psychotherapy is directed specifically toward altering eating behavior. The researchers found that 

in patients who switched antidepressant medications partway through the trial when they either 

did not respond to the first or experienced severe 

side effects, the change yielded additional improvement. Studies that demonstrate the effectiveness 

of different types of therapies in combination with 

one another are particularly important, given the 

cost considerations of various treatment strategies, 

yet this type of research is not likely to be undertaken by pharmaceutical companies or other 

organizations outside the Federal Government.12

Mental Health and Other Illnesses

Mental Health and AIDS. In the progression 

of AIDS, issues of mental health and behavior arise 

at every point — from the risk-taking behavior that 

contributes to transmission of HIV; to the early signs 

of HIV entry into the central nervous system; to the

psychological, social, and behavioral challenges faced

by all HIV-infected individuals and their friends and

families; to the devastating late-stage dementia that

affects many AIDS patients; and ultimately to the 

profound loss and bereavement suffered by those 

left behind.

Recent accomplishments of basic and 

behavioral research related to mental health 

and HIV/AIDS include:

• Successful behavioral interventions developed 

to address the risk factors of specific groups 

with increasing rates of HIV transmission, 

including women and people with severe 

mental illness.

• Refined methods for the early detection of 

cognitive impairment in people infected with 

HIV who have no other medical symptoms.

• Scientific understanding of the biochemical 

events that take place in the brain and central 

nervous system during various stages of 

HIV infection.

• Animal models developed that permit closer 

investigation of different aspects of HIV infection of the central nervous system.

Research on the pathogenesis of HIV infection 

will ultimately lead to better ways to treat — and 

possibly prevent — the cognitive and motor impairments caused by HIV/AIDS.13

Mental Health and Physical Disorders. 

Mental disorders, in particular depression, coexisting with physical illness can increase levels of disability, increase use of health services, and reduce 

effectiveness of rehabilitation efforts. Mothers with

mental and/or physical disorders, due to increased 

disability, have been found to have less effective 

parenting behaviors, which in turn, increases risk 

for behavior problems in their children. Women live
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longer than men, with more physical disabilities;

women are therefore important to study with 

regard to the role of late-life depression, which in 

itself can create disability. Many physical disorders 

may confer risk for depressive or anxiety symptoms

through the immune and cardiovascular systems 

(e.g., cortisol, cytokines, inflammation, pain), and 

conversely depressive and anxiety symptoms can 

exacerbate the course of a physical illness by poor

treatment adherence and lack of self care. Treatment 

of mental disorders that are comorbid with physical

disorders has been found to reduce hospitalization 

and rehabilitation services and to improve functioning. More research is needed on how to prevent 

and treat comorbid mental health problems that 

are common with physical illnesses (e.g., stroke, 

hip fractures, cancer and its treatments).

RESEARCH 

RECOMMENDATIONS

Research Across the Life Span

• Conduct both basic and applied research 

related to women’s mental disorders across 

the life span to explain gender differences in 

age of onset, and in age-related differences in 

the course of mental disorders. Attention to 

differences in developmental trajectories within

biological and psychosocial contexts is necessary 

in research that considers either gender differences in mental disorder or variation among

females. There is a need to study postmenopausal women from their 70s through their 

90s to find out why in this age group women 

often are more resilient than men.

Ethnic Minority Women

• Expand knowledge about mental disorders 

in ethnic minority women in terms of understanding the context and consequences of 

psychopathology, clinical course, intervention 

effectiveness, and service use related to these 

disorders. There is compelling empirical and 

theoretical evidence regarding important ways 

in which the varied cultural backgrounds 

of patients generally and ethnic minority 

patients in particular affect the content and 

form of behavior, psychiatric problems and 

the manifestations of psychiatric conditions, 

the context of evaluation, and the meaning 

of psychiatric disorder. Unlike other fields 

in medicine, where there are more objective 

measures and parameters of morbidity, diagnosis in psychiatry has relied almost entirely 

on signs, symptoms, and behavior that often 

have subtle differences not only from one 

mental disorder to another but also differences from one gender to another, one ethnic

group to another, and one age group to another.14

Because culture and ethnicity play such profound

roles in shaping and defining the context and 

the content of both normal and abnormal experience, variables must be taken into account in 

studies on the nonbiological issues affecting 

mental disorders in ethnic minority women. 

With the emergence of research results pointing to a combination of medication and psychosocial treatment as the new standard for optimum treatment for mental disorders, attention 

to correct diagnosis takes on increased significance. The combination of misdiagnosis of 

disorders and inappropriate prescription of 

powerful medications has the potential of 

creating very serious problems for the patient 

and the clinician. Recent research in psychopharmacology reveal significant interethnic 

variation in response to an array of psychotropic medications. For example, research on 

lithium — one of the drugs used to treat manic

depressive disorders — has consistently demonstrated ethnic variations among Asian, black, 

and white groups, but most of these studies 

have excluded females. Thus the research 

agenda to address the mental health concerns 

of ethnic minority women would encompass 

both biological and psychosocial factors.15
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Impact of Violence

• Conduct long-term studies to determine the 

psychological and biological consequences of 

sexual assault and other abuses. Overwhelmingly,

women are the more likely victims of violent

abuse. A study of a representative national 

sample of women indicated almost 13 percent 

of women (about 12 million) have been raped 

and 11 percent more have been the target of 

aggravated assault at least once. Evidence indicates that mental disorders are more prevalent

among women with a history of child abuse. 

Data are emerging that childhood sexual abuse 

is strongly associated with high-risk behaviors 

that can contribute to HIV/STD infection. PTSD 

is an anxiety disorder first characterized in male

combat veterans, but soon found also to affect

female victims of trauma. Although many forms 

of intervention exist for rape-related PTSD symptoms, only a few well-controlled studies have 

been conducted to systematically evaluate the 

treatment response of women who have been 

the victims of sexual assault. HIV-positive 

women tend to be victims of partner violence.

Gender Differences in Psychopharmacology

• Increase the knowledge base of gender differences in psychopharmacology. Epidemiologic 

surveys indicate that women are prescribed 

and use psychotropic medication at twice the 

rate of men. Historically, this knowledge gap 

is due, in part, to the exclusion of women of 

childbearing age from drug-development trials

because of fear of unintended birth defects. 

This research strategy has not furthered the 

understanding of gender differences in pharmacokinetics and pharmacodynamics of psychotherapeutic drugs. Research should be 

undertaken to study the effects over time of 

psychotropic drugs and hormones, because 

millions of women take antidepressant drugs 

and hormone replacement medications concurrently and regularly.

Recommendations from Philadelphia Workshop

The following recommendations were 

reported from of the Philadelphia regional meeting in September 1996.

• Encourage research on the interactions among 

biological, psychological, and social factors 

related to mental disorders across the life 

span of women.

• Encourage research to identify the social, 

developmental, and biological factors that 

predispose adolescent girls and young 

women to a sharp increase in rates of 

mood, eating, and anxiety disorders.

• Stimulate research on gender differences 

in brain function, specifically the effect of 

gonadal hormones on the developing brain 

and their relationship to the formation of 

sexually dimorphic brain structures and 

processes and how these distinctions could 

be related to gender differences observed 

in persons affected by mental disorders.

• Further explore the findings that levels of 

neuroactive peptides, such as cholecystokinin (CCK), may be altered in women 

with bulimia and that lower levels of this 

peptide also correlate with higher scores 

on measures of anxiety and anger. Attempt 

to link these findings with studies showing 

that CCK interacts with serotonergic neurons,

which have been implicated in the etiology 

of bulimia.

• Encourage and support research on 1) psychological and biological effects of sexual assault 

in childhood and 2) intervention research 

designed to prevent and/or treat the longterm mental health effects of experiencing 

abuse and violence, especially so that 

women can engage in self-protective 

health behavior.
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• Conduct research on the co-existence of 

drug dependence with psychiatric disorders, 

especially depression, PTSD, anxiety disorders, 

and eating disorders.

• Expand research examining the development 

and effectiveness of treatment models, which 

are specific to the unique needs of women, for

treatment of psychiatric disorders such as depression, anxiety, PTSD, and eating disorders. These

models must also be culturally relevant and

address developmental life span issues.

• Address diversity in all research studies. 

Many measurement tools used today were 

normed on white male reference groups. These

tools need to be re-examined and validated for 

use with females and diverse ethnic groups. 

Similarly, there is need for female-centered 

models of treatment. In developing these models,

researchers need to be cognizant of the variables

important in women’s mental health, including

racial, religious, socioeconomic status, and 

sexual orientation.

• Integrate cross-disciplinary research from 

molecular level through societal level. Mental 

disorders are complex problems that involve 

mutually interactive biological, behavioral, 

and societal factors. Research is needed that 

integrates across these levels of analysis to 

understand this complexity and provide comprehensive solutions. Given that researchers 

typically receive training in only one of these 

levels, cross-disciplinary collaborations are 

needed to develop more integrated programs 

of research. Prime topical areas for such crossdisciplinary collaborations in women’s mental 

disorders include AIDS/HIV, abuse, posttraumatic stress disorder, and depression.

Recommendations from Bethesda Workshop

The following recommendations came from 

the Bethesda national meeting in November 1997.

• Conduct interdisciplinary research. Interdisciplinary research is important in all 

areas, especially in preventive and life 

span/longitudinal research.

• Determine what is “normal.” Research is needed 

on the normal aging brain in women. Then 

based on what is normal, abnormality can 

be defined appropriately. The definition of 

“a normal person” as being someone who 

does not meet criteria for any diagnosis should

include what we know about normal brain 

development. The effects of genetics and the 

hormones (e.g., estrogen, testosterone, thyroid 

hormones) on normal brain development 

should be studied.

• Examine resiliency. Investigate why some 

families develop female children who are 

resistant to mental disorders such as eating 

disorders. What helps most young girls not 

to develop this mental disorder? What makes 

them resilient against the overwhelming 

societal pressures to define themselves in 

terms of body image?

• Examine comorbidity. The traditional comorbidity definition looks at the relationship 

between drugs and alcohol and mental disorders and mental disorders with physical 

disorders, but research should broaden this 

concept to examine the relationship among 

mental disorders. For example, the work of 

Breslau and Kessler indicates that early anxiety 

disorders predispose to depression, for both 

men and women. Anxiety disorders are significantly more prevalent in girls than in boys, 

which leads to higher incidence of depression 

in women than in men.

• Conduct mental disorders research outside of 

traditional clinical settings. This is particularly

important for women who may seek treatment

more frequently than men so that clinic samples

may therefore be biased. Examples of such 

studies are differing brain development in boys 
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and girls, studies of mental disorders of poor

women living in the community, or mental 

disorders studies in sites like jails, domestic 

violence centers, and primary health care settings. This includes basic research — population

studies on basic brain development, intervention

studies in populations that are difficult to reach

and that generally do not participate in research

studies (e.g., poor women, minority women).

Intervention studies and community population

studies should be conducted in service sites 

that are not mental health sites (e.g., jails, 

domestic violence shelters, homeless shelters, 

primary care settings, and schools). It is imperative that researchers change their venue from 

the clinical research setting and concentrate 

their investigations in the “real world” using 

probability (not convenience) samples.

• Study reproductive hormones and their role 

in women’s mental health, especially during 

the critical life transitions where they are particularly important — menarche, pregnancy, 

postpartum, and menopause. Study the effects 

of drugs on the mental health of mother and 

baby both short- and long-term outcomes. 

Study the increased incidence of depression 

in women at menarche and during the perimenopausal period. Investigate the effect of 

reproductive hormones on mental functioning

throughout the life span.

• Study mood and menopause. A recent 

increase in interest about cardiovascular 

diseases, mineral corticoid diseases, and 

reproductive diseases associated with menopause has not been matched by research 

related to mental illness associated with 

menopause. With the preliminary finding 

that there is new and increased onset of 

major depressive disorder in the perimenopausal years, the effect of hormone replacement on mood is an area that deserves 

particular attention. An offshoot of this 

finding that also needs investigation is how 

major mental illnesses — depression, anxiety, 

and schizophrenia — are affected by changing

gonadal hormones.

• Research the prevention of mental disorders 

in women. Researchers should take a life span 

perspective, looking especially at the developmental precursors and the gender differences 

in early developmental trajectories and the 

likely precursors to mental illnesses.

• Identify significant changes in the health care and 

social services systems that are beginning to give 

back enormous caregiving responsibilities to women.

This extra burden is expected to have enormous

and important mental health implications for

women. Research is needed to identify, prevent,

and treat the serious mental illnesses resulting 

for women who are overburdened by these 

added responsibilities.

• Study nutrition and eating disorders. This 

area is of enormous importance to women 

themselves and because of women’s general 

role as caregiver and provider of nutrition. 

Investigations of how women and men vary 

in addictive behaviors, ranging from drugs 

to food, are needed. For instance, men’s addictions may center primarily on substances, 

whereas for women, the “drug” of choice 

may be food.

• Research schizophrenia. Schizophrenia is 

believed to be a disorder in which the genetic 

or environmental “insults” occur in the prenatal

period; therefore, researchers need to study 

brain development and brain building in general and how that differs between girls and 

boys. The timing of these “insults” may have 

differential consequences for boys and girls. 

An early “insult” to the brain may occur, but

because of the way the brain develops — prefrontal areas of the brain are not fully developed

until 18 to 20 years of age — the areas involved 
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in producing psychotic symptoms are not fully

developed and the disorder is not expressed 

until those areas of the brain are developed. 

In high-risk children, for example, early cognitive deficits have been found in people who 

later become psychotic. Males have higher rates 

of “early” onset schizophrenia, while females 

are more frequently among late onset schizophrenia. Population-based studies to discover 

what constitutes normal brain development 

can illuminate the differences in aging of the 

brain by sex.

• Study mental disorders in special populations of 

women with greater needs especially difficultto-reach populations, e.g., women who are 

poor or homeless, immigrants, women in 

jails, delinquent girls, women with physical 

disabilities, women who are developmentally 

disabled, lesbians (and subgroups like lesbians

with physical disabilities), and rural women. 

These women have special treatment needs and 

are at much greater risk than women with greater

economic resources and may have different etiologies needs and outcomes compared to middleclass women from easy-to-reach populations.

Priorities for subgroups to highlight should 

be garnered by ascertaining those that are fairly 

frequent and more likely to occur, then determining whether each of those groups has procedural 

risk factors for mental disorders. The most important

subgroups of women to study will likely include:

• Women living in poverty. The majority of people 

living in poverty in the United States are women

and their children. The women have a very different health profile than men. Because they lack 

access to treatment, these women have not 

been included in most studies. Researchers 

who are interested in studying people living at 

or below the poverty line have found success 

by reaching out to women.

• Women in the justice system. Overlap research 

studies with the criminal justice system, 

juxtapose the untreated mentally ill women in the

criminal justice system. This emphasis will help

fuel financial support for research on untreated

mental illnesses in women in general.

• Homeless women.

• Deliquent girls. Rates of delinquency among girls 

is an emerging issue. Greater understanding of 

risk factors (e.g., attention deficit hyperactivity 

disorder) is needed to develop prevention 

efforts appropriate to girls.

Future Areas for Research on Mental Disorders

This research on mental health of women and 

gender differences is important to improve the mental

health of U.S. women and to provide critical insights

into the origins of mental disorders; such research 

will continue to be emphasized.

Research on the causes, prevention, and treatment of all forms of depression continues to be 

of the highest priority to NIMH. Research on manicdepressive illness, or bipolar disorder, will be particularly emphasized. Based on the accumulating 

knowledge of mental disorders, extremely promising

research directions include the heritability of depressive disorders; the roles that interactions of inherited

factors with a person’s environment may play in 

inducing depression; the prevention of depression,

especially through interventions during childhood; 

and the discovery of new and improved treatments 

— both behavioral and medical — for depressive 

disorders. The therapeutic effect of St. John’s Wort

(hypericum), an alternative natural treatment for

depression, will be rigorously evaluated for benefit 

or risk in clinical depression.

While long suspected, research findings are 

now confirming that hormones play significant roles 

in many mental disorders. Certainly effects of steroidal hormones appear to be of primary importance 

in the pronounced gender differences found in the

prevalence of certain mental disorders — for example,

depression, which affects women two to three times 
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as often as men; in the expression of a disorder, 

as in the gender-related differences in subtypes of 

schizophrenia; or in the pathogenesis of disorders

affecting only women, such as postpartum psychosis,

which may result from the sudden fall in estrogen 

and progesterone concentrations immediately 

after childbirth.

Steroid hormones also are involved in the 

effects of stress on brain development and aging, as

well as on normal brain functions such as cognitive

and emotional processing. Estrogen has begun to 

reveal some unsuspected talents, such as an apparent ability to preserve and even improve some of 

the brain’s highest functions like learning and memory. At the same time, there is epidemiologic evidence

that estrogen may exert protective effect in disorders

like Alzheimer disease or schizophrenia.

Like estrogen, corticosteroids have been shown 

to have profound effects on the morphology of hippocampal neurons. It has long been known that various forms of stress cause changes in expression and

release of CRF (corticotropin-releasing factor)-ACTH

(adrenocorticotropic hormone), and cortisol that are

accompanied by changes in behavior, cognition, and

emotion. Similarly, recent work has shown that stressors occurring in the neonatal period may alter the 

set point of responsiveness for corticosterone release 

for life. NIMH expects to expand research on the 

study of hormones and their impacts on brain development, aging, behavior, and gender differences in

mental disorders.

References 

1 Murray CJL, Lopez AD, eds. The global burden of 

disease: a comprehensive assessment of mortality and 

disability from diseases, injuries, and risk factors in 

1990 and projected to 2020. Cambridge, MA: Harvard

University Press, 1996.

2 Kennedy C, Carlson D, Ustun TB, Regier DA, Norquist 

G, Sirovatka P. Mental health, disabilities, and women: 

A policy-oriented data review. J Disability Policy Stud

1997;8(1&2):128-56.

3 Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes

M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and

12-month prevalence of DSM-III-R psychiatric disorders 

in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry 1994;51:8-19.

4 Desjarlais R, Eisenberg L, Good B, Kleinman A. World 

mental health: Problems and priorities in low income 

countries. New York: Oxford University Press; 1995.

5 Weissman MM, Olfson M. Depression in women: 

implications for health care research. Science 1995;

269:799-801.

6 Nolen-Hoeksema S, Girgus JS. The emergence of 

gender differences in depression during adolescence. 

Psychol Bull 1994;115(3):424-44.

7 Blehar MC, Oren DA. Women’s increased vulnerability 

to mood disorders: Integrating psychobiology and 

epidemiology. Depression 1995;3:3-12.

8 Pratt LA, Ford DE, Crum RM, Armenian HK, Gallo JJ,

Eaton WW. Depression, psychotropic medication, and risk

of myocardial infarction. Prospective data from the Baltimore ECA followup. Circulation 1996; 94(12):3123-9. 

9 Foa EB, Hearst-Ikeda D, Perry KJ. Evaluation of a 

brief cognitive-behavioral program for the prevention 

of chronic PTSD in recent assault victims. J Consult 

Clin Psychol 1995;63:948-55.

10 Herzog DB, Nussbaum K, Marmor A. Comorbidity 

and outcome in disorders. Psychiatr Clin North Am

1996; 19(4):843-59.

11 Mann T, Nolen-Hoeksema S, Huang K, Burgard D, 

Wright A, Hanson K. Are two interventions worse 

than none? Joint primary and secondary prevention 

of eating disorders in college females. Health Psychol

1997;16(3):215-25.

12 Walsh BT, Wilson GT, Loeb KL, Devlin MJ, Pike KM,

Roose SP, Fleiss J, Waternaux C. Medication and 

psychotherapy in the treatment of bulimia nervosa. 

Am J Psychiatry 1997;154(4):523-531. 

13 Kelly JA, Murphy DA, Washington CD, Wilson TS, 

Koob JJ, Davis DR, Lepezma G, Davantes B. Effects of

HIV/AIDS prevention groups for high-risk women in

urban clinics. Am J Public Health 1994;84:1918-22.

14 Mezzich J, Kleinman A, Fabrega H, Parron D, eds. 

Culture and psychiatric diagnosis: a DSM-IV Perspective.

Washington, D.C.: American Psychiatric Press, 1996.

15 Parron DL. Culture, gender, and diagnosis of psychiatric

disorder. Presentation at Realizing a Gender-Sensitive

Health Care. Amsterdam, The Netherlands: Dutch 

Foundation of Women and Health Research, 1997.
NEUROSCIENCE

BACKGROUND 

S hortly before establishing the Office on 

Research on Women’s Health (ORWH), Congress declared the 1990s to be the Decade of

the Brain.1,2 Policymakers, scientists, and clinicians

recognized that neuroscience research was rapidly

expanding because of the refinement of theories and

principles, advances in genetics and molecular biology, and new imaging techniques. New understandings about genes and their expression, as well as the

activities of neurotransmitters, nerve growth factors,

and other signals, opened up new avenues for study.

The interactions of neurotransmitters and hormones and the actions of drugs on these chemicals 

are major areas of research. Recently, the study of 

the differences between the sexes had added a new

dimension to these investigations. Neurotransmitters

relay tiny changes in electrical impulses from one 

neuron to another and bind to specific receptors. 

Neurotransmitters can be found throughout all body

systems, performing different functions at receptors 

in different locations: initiating an action in one 

place and inhibiting a response in another. Hormones

form the second great communication system in the

body, overlapping with the neurotransmitters, as some

chemical messengers affect nerves and travel in the

bloodstream. In the last decade, basic and clinical

research have revealed that varying gonadal hormone levels during the menstrual cycle and across 

the life span affect virtually all components of the 

nervous system.

Recent advances in basic and clinical neuroscience have enhanced the ability of researchers 

and clinicians to understand the neurobiology underlying diseases and conditions such as Alzheimer 

disease, anxiety disorders, chronic pain, depression,

epilepsy, multiple sclerosis, Parkinson’s disease, 

schizophrenia, and stroke. Such advances have

occurred, in part, as a result of improvements in 

tools and technologies for studying and mapping 

the brain and its functioning in health and disease.

New understandings of brain disorders have been

achieved because of the focus on the roles of hormones and neurotransmitters such as estrogen, 

progesterone, dopamine, serotonin, and other 

naturally occurring chemical substances in cognition

and emotion. Opportunities for direct simultaneous

study of physiology and mental functioning have 

come from noninvasive imaging techniques. Using 

new and refined techniques, neuroscientists have

begun to examine the physiology, neurochemistry, 

and anatomy of the human brain in living subjects.

Supplementing older techniques such as electroencephalography (EEG), these new techniques include

positron emission tomography (PET), computer 

tomography (CT), magnetic resonance imaging 

(MRI), and magnetic source imaging (MRS).

With the increased attention given to research 

on women’s health and to gender differences, studies

using combinations of these neuroanatomical and

behavioral techniques have identified sex differences 

in the manifestation of brain disorders and the 

Cochairs

Constance W. Atwell, Ph.D.

National Institute of Neurological Disorders and Stroke

National Institutes of Health 

Howard Kurtzman, Ph.D.

National Institute of Mental Health

National Institutes of Health 

Bruce S. McEwen, Ph.D.

Rockefeller University

Rapporteur: Barbara P. Ordway

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influence of reproductive endocrine disorders in

women and men suffering from a variety of diseases,

such as epilepsy.3-5 Research has expanded on the

influence of hormonal states on important behavioral

functions such as cognition and conscious emotion 

in health and disease.6,7

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT 

OF ORWH

The broad recognition that scientifically and 

clinically significant sex differences exist in many

aspects of brain development, organization, and 

functioning is a recent change and an important 

one for research. Building on the findings of the 

last decade, scientists are addressing questions of 

sex differences in study design. Increasingly, female

animals are being used in research, particularly for

investigating brain disorders that affect women more

than men, such as multiple sclerosis (MS) and myasthenia gravis. With attention to hormonal levels and

reproductive stage, questions can be posed more 

precisely and research findings interpreted more 

successfully. Research advances in which sex differences play an important role have been noted across

the following areas: development of the brain and 

nervous system, cognition and the effects of hormones, manifestations of brain disorders, sensory 

perception and pain perception, responses to treatment of disease, and balance and the vestibular 

system, with the aid of methodological developments in research into sex differences. 

Development of the Brain and Nervous System

Although there is much to be learned about 

normal brain development, explorations of genetic 

and environmental influences have shown some gains.

The interaction between the environment and genetic

makeup of the individual through critical periods in

the development of the brain creates a pattern of connections unique to each person, but recognizable in

general terms, as neurons migrate and connections 

are formed before and after birth. Scientists have 

identified the defective gene responsible for about 

two dozen neurological disorders and the chromosomal location of the defect in 50 to 100. A genetic

component has been indicated in the muscular 

dystrophies, some forms of mental retardation, 

manic depression, and other neurological disorders.

Still unknown are the factors that determine variations in genetic expression of a single gene abnormality, such as what contributes to the early or late

start or the severity of a disorder. However, characterization of genes and gene studies have improved

diagnosis and the potential for treatment.

New evidence for genetic imprinting (differences in gene expression according to the parent 

of origin of the gene) has been found in cognition 

and behavior. Personality effects have been noted 

in Turner’s syndrome, depending on whether the 

X chromosome is inherited from the mother or 

father.8 Mutations in mitochondrial genes have 

been found to cause rare neurological disorders. 

For example, a mitochondrial defect due to a gene

inherited from the mother leads to hearing loss 

(triggered by an antibiotic).9

Communication between the endocrine system

and the nervous system seems to cause anatomical 

differences in the developing brain and certainly 

helps the brain to adjust its performance and control 

of behavior in response to changes in the environment.

Specific receptors uniquely responsive to specific hormones are found in selected classes of neurons in the

brain. Under the control of the pituitary, which is 

itself controlled by the hypothalamus, these receptors

process the signals, and the cells release neurotransmitters and other hormones into the blood. These 

hormones act on the pituitary, the brain itself, the

adrenal gland, and other tissues. The brain contains

receptors for thyroid hormones and steroid hormones

(estrogens, androgens, progestins, glucocorticoids, 

mineralocorticoids and vitamin D). 
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Along the hypothalamic-pituitary-adrenal (HPA)

axis, responses to stress and to changes in circadian

and reproductive cycles stimulate hormone production. In the brain, these hormones alter synaptic 

transmission as well as the structure of brain cells,

changing the circuitry of the brain and its capacity 

for neurotransmission over the course of hours and

days. The complex interactions of hormones and 

bodily functions are only beginning to be explored 

(see below). For example, the presence of androgen

receptors on the motor neurons and estrogen receptors on the sensory neurons may have implications 

for hormone treatment to enhance regenerative

processes and recovery of function.

New developments in imaging techniques have

enabled the examination of functional neuroanatomy

and the effects of therapies on the brain. By means 

of imaging, differences in brain organization between

men and women have been revealed, as well as new

information about brain asymmetry.10 These findings

have led to hypotheses about the effects of laterality 

on function and on the differences in the male and

female brain and how these arise. Sex differences are

seen in brain organization for language, which can 

help explain sex differences in prevalence and symptoms of language and learning disorders.11,12 The

implications of sexual dimorphism for susceptibility 

to stress and injury and response to congenital 

abnormalities and injury remain to be explored.

Sex Differences in Cognition and Effects 

of Hormones

Scientific evidence on the effects of sex hormones on adult cognition has emerged since the 

1991 meeting organized by ORWH in Hunt Valley,

Maryland, to formulate a research agenda for women’s

health. Through basic science and clinical research, 

it is now known that varying estrogen and progesterone levels across the menstrual cycle and across 

the life span can influence an individual’s performance on a number of cognitive tasks.

Estrogens have been shown to have many 

effects on the brain, beginning at gestation and 

continuing into adulthood. Investigators are exploring the relation between estrogen and attention and

cognition across the life span. Many of the effects 

of estrogen implicate areas of the brain that are

involved in memory processes and their alteration 

with age in healthy people, and this is important 

for understanding the pathophysiology and consequences of neurodegenerative disease.13,14 Preliminary studies conducted in recent years have shown 

that the decline of estrogen and progesterone levels 

at menopause is associated with diminished cognition, but that estrogen replacement therapy (ERT) 

in postmenopausal women can enhance performance

of cognitive functions.7,15 In addition, there is now 

evidence that ERT can prevent or delay the onset 

of Alzheimer disease and stroke by affecting nervegrowth-factor systems, particularly cholinergic neurons

(neurons that liberate or are activated by the neurotransmitter acetylcholine) in the basal forebrain.16

Recent research on animal and human subjects 

is challenging the long-held assumption that the 

adult brain does not undergo changes in its structure,

particularly in relation to the actions of circulating 

hormones. It has been demonstrated that estradiol 

and progesterone have important effects on adult 

brain structure and function. Animal studies indicate

that synaptic density of the hypothalamus is affected 

by estradiol and progesterone and influences the 

cyclicity of sexual behavior, as well as the cyclicity 

of performance on spatial reasoning and memory

tasks.14,15,17 Other research suggests that hormonal

modification of the hippocampus may contribute to

cognitive changes during menopause, as well as in 

temporal lobe epilepsy associated with polycystic

ovaries or hypogonadotrophic hypogonadism.18

Other sex differences involve glucocorticoid 

hormones. In a study of the effects of gender and 

age on 24-hour cortisol levels, cortisol levels were 

seen to be lower in young adult women than in 
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men, because the female response to circadian 

signals is slower and of lesser magnitude and the 

return to quiescence is more rapid. In older women

compared with men of the same age, HPA reactivity

was greater.19 Older women also showed a significant correlation with cognitive decline of an increment in baseline urinary cortisol secretion over a 

3-year period.20 This is relevant to changes in the

brain, because there is evidence from animal studies

and some evidence in humans for a link between

stress, glucocorticoid elevations, atrophy or damage 

to hippocampal neurons, and cognitive impairment.21

Sex Differences in Manifestations of Brain Disorders

Sex differences have long been recognized in 

the frequency and severity of a number of neurological and mental brain disorders (e.g., stroke, migraine

headache, sleep disorders, movement disorders such 

as torticollis, immunological disorders such as multiple sclerosis, and mental disorders such as depression,

schizophrenia). Recent work confirms the importance

of gender considerations in neurology and psychiatry

and indicates that reproductive hormones (gonadal

steroids) may play an important role in pathophysiology and possibly treatment. 

Several examples illustrate how such research 

can have both theoretical and clinical implications. 

Sex differences were noted in a prospective Finnish

study that examined diabetes mellitus as a risk factor

for death from stroke, with women being at a higher

risk than men.22 Similarly, women with myocardial

infarction treated with thrombolytic therapy have a

higher incidence of hemorrhagic stroke.23 This 

may relate to higher rates of cerebral blood flow 

in healthy women compared with men.

Levels of ovarian hormones are linked to 

timing and incidence of migraine headache24 and

epileptic seizures,25 as well as to sleep disorders, 

especially sleep apnea,26 and torticollis.27 Although

premenopausal women have less cardiovascular 

disease than men and estrogen protects women 

from stroke, there appear to be complex interactions, e.g., ERT increases risk for stroke in women 

with a history of migraine.28 Paradoxically, however, ERT may also be the best form of therapy for

some women with migraine.29 Progesterone treatment appears to reduce seizures,30 but doubleblind, placebo-controlled studies are needed 

to verify this finding. Self-injurious behavior in 

mentally retarded females is influenced by cyclic 

hormone levels.31

Meningiomas and neurofibromas have estrogen

and progesterone receptors, and these neoplasms 

are sensitive to hormone levels.32 Observation of the

occurrence and size of such tumors will be needed 

in the context of increased use of estrogen and progesterone replacement (HRT). 

Sex differences have also been documented 

in the manifestations of Alzheimer disease (AD).

Women are at a higher risk for late-onset familial 

AD, and this might be related to gender differences in the apolipoprotein E epsilon 4 allele 

(EPOE) heterozygous genotype, which is more 

common in women.33 Women with AD were 

found to perform worse than men with AD on 

measures of semantic memory and language, 

whereas healthy women performed better than 

healthy men on these tasks; however, this area 

of research is still open to study.34,35 Neuropsychiatric manifestations in AD are also more severe 

in women, which is consistent with the greater 

frequency and severity of depression experienced 

by women.

In contrast, schizophrenia manifests itself less

severely in women than in men. The symptoms 

occur later in life for women than for men, are 

less severe, have a milder course, and show a 

better outcome with treatment. It is noteworthy 

that this difference may be age related, as elderly

women with schizophrenia have more severe 

symptoms than elderly men.
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Estrogen and HRT affects the frequency and 

severity of symptoms of depression, anxiety, and 

eating disorders. Interactions of HRT with antidepressants and tranquilizers are recognized. In addition,

clinical observations indicate that women with a 

history of head injury are more sensitive to benzodiazepines (Valium), sedatives, and hormone 

replacement than other women.

Sex Differences in Sensory Perception and Pain

Increasing numbers of studies have produced 

evidence for sex differences in response to noxious

stimuli, trauma, and the experience of pain, although

the data are inconsistent, with many confounding 

variables, and the differences are relatively minor.36

Females often report higher pain levels than men 

for the same stimulus intensity.36-38 Women who 

suffer pain during menstruation (dysmenorrhea) 

show increased sensitivity to pain in their muscles 

in response to pressure (the usual experimental 

pain inducer).39-41

Sex differences in mechanisms that modulate 

pain exist in animals; the mechanisms that produce

these differences are not yet understood. Studies 

suggest that the effectiveness of treatment for chronic

pain may be different for women and men. Estrogen is one modulator of the mechanisms of pain

relief.36,42 Basic research on pain has shown that 

estrogen appears to induce analgesia through a 

different pathway in female mice than in male mice.

New discoveries of estrogen receptors throughout 

sensory/perceptual nervous pathways are changing

views on estrogen’s role. Another recent discovery 

is that sex-linked genes are associated with nonopioid analgesia in female mice.43

Sex differences are reported in coping 

strategies, internal responses to pain, and to 

endogenous pain modulation as well as reactions 

to pain medication. Studies using animal models 

and humans have demonstrated that pregnancy 

and parturition are associated with elevated pain

thresholds in the mother.44 During hormonestimulated pregnancy, opioid-mediated maternal 

analgesia involving the spinal cord dynorphin/

kappa-opioid system attenuates the pain associated

with late pregnancy and labor.45 In fact, kappaopioids produce greater analgesia in women than 

in men.45 Thus, drugs developed in studies with 

male research models and tested in males may 

be differentially effective in relieving pain in

females.36,46 Informed research could lead to 

the development of new interventions that are 

more effective in mitigating pain in both men 

and women.

Sex Differences in Response to Treatment 

of Disease

The increased recognition of sex differences 

in health and brain disease has implications for 

examining sex differences in response to treatment. 

The literature is limited, however, since most studies

were conducted with men only or were not evaluated

for sex differences. It is essential to integrate measurement and analysis of sex differences into research on

treatment and on disease presentation. 

Research in animals suggests that the development of drugs for the treatment of stroke, for 

example, should evaluate potential sex differences 

very carefully. In the rat, N-methyl-d-aspartate 

“. . . hormones effect epilepsy and epilepsy 

effects hormones, and there is a relationship 

between hormones and seizures at puberty, over 

the menstrual cycle, and at menopause. . .”

Linda Lindahl 

Epilepsy Foundation 

of America
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

antagonists have been reported to induce greater 

age-associated neuronal necrosis in females than 

in males.47

Sex Differences in Balance and the 

Vestibular System 

Women and men often differ in their organization of body movement, which is possibly 

related to hormone levels and which may then 

place them at greater risk for falls in old age. 

Also, some younger women experience episodes 

of falls that appear to be linked to hormone cycles. 

In the forebrain, ovarian hormones affect the nigrostriatal system, as well as the cerebellum, and affect

motor coordination.

Methodological Developments

The number of studies in which sex and 

gender differences are included as study variables has increased since 1991. These range from 

studies focusing on the differences in the structure and functioning of the brain in males and 

females to research on the effects of hormones 

in the brain, the central and sympathetic nervous 

systems, and brain disease manifestations and 

treatment in women and men. The combination 

of basic and clinical neuroscience methodology 

has enabled examination of sexual dimorphism 

developmentally. 

Animal studies provide the foundation for 

integrative research on neuroanatomy, neurochemistry, neuroendocrine function, and neurophysiology. 

The developmental perspective examines sex differences across these variables in relation to brain development and maturation. Neuroimaging techniques,

when combined with clinical and neurocognitive

assessment, are powerful tools for identifying the

mechanisms for sex differences in healthy brain 

function and in specific disease states. Perhaps as

important, investigators using these technologies 

can extend and test hypotheses that have implications for intervention. 

Women subjects are needed for clinical studies; they volunteer less often than men. The fact 

that female hormone levels are variable should be

viewed as an opportunity for investigation rather 

than a barrier. Consideration of hormone levels 

adds to methodological complexity but has potential for new theoretical insights.

GAPS IN KNOWLEDGE

The question that arises in many studies cited 

here is what difference do sex differences make for 

normal functioning? The baseline data on normal 

functioning are lacking for children, girls at puberty,

pregnant and lactating women, and, in general, 

women throughout all stages in the reproductive 

cycle. Estrogen has been emphasized, and many 

studies of the effects of estrogen replacement are 

under way; however, distinctions must be made

between different estrogen and combination hormone therapy preparations, some of which are 

delivered orally and others transdermally. Other

gonadal hormones warrant study: progesterone 

and androgen levels in women and their effects. 

It is known, for example, that progesterone levels 

at the time of injury affect the experience of pain.

The use of female animals or of women in 

research must be justified and appropriate. Large

enough samples must be included in study designs 

to allow for the heterogeneity of women. The study 

of sex and gender as factors in brain function requires that we reinvigorate the integrative approach 

to neuroscience and recognize that studies on whole

animals are essential. Expertise and sophistication 

in these areas need to be appreciated by review 

panelists (both grant and journal peer reviewers) 

and also developed in young students through 

education and training.

Not enough data are available for evaluation 

and comparison. Many issues are ready for study:

social and cultural impacts on brain function, stress,

trauma, and injury; brain plasticity and rehabilitation;
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VOLUME 2

strategies for coping with pain; and the effects of 

drug abuse on the nervous system, to name a few. 

The differences to be discovered between men and

women in health and disease are not deficits, but 

provide avenues for new analysis and treatment 

interventions tailored to the group, the individual, 

and the circumstances.

RESEARCH 

RECOMMENDATIONS

Virtually all components of the nervous 

system respond to gonadal hormones. Virtually 

all disorders involving the nervous system are 

affected by gonadal hormones. The recent interest 

in gonadal hormone effects on brain function and 

the nervous system have been galvanized by evidence about neuroprotective effects of estrogen 

replacement therapy on Alzheimer disease.

• Raise awareness in the neuroscience research 

community about the importance of sex 

differences and hormonal influences on 

all aspects of brain function.

– training and retraining

– research design 

– peer review

• Research basic mechanisms to develop 

better prevention and treatment strategies.

– neural systems

– plasticity and repair

– mechanisms of hormonal action

• Focus on life-span issues, developmental stages,

and hormonal states in females and males.

– impact of early life events on later 

neural function

– increased emphasis on neurobiology 

of childhood and adolescence

– careful measures and analysis of 

hormonal states

– neurobiology of pregnancy, postpartum, 

and lactation states

– further study of the neurobiology of 

androgen in males and females

• Study neurobiology of interactions of gender 

and gonadal hormones with endocrine, 

immune, and other systems and disorders.

– neurological disorders

– mental disorders 

– autoimmune disease 

– sensory and motor disorders

– pain disorders

• Explore impact of social and physical environment on neural development and function.

– gene and environment interactions

– life-span perspective

– stress and trauma 

– nutrition

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Medicine, National Academy of Sciences. Washington, 

D.C.: National Academy Press, 1992.

2 Carey J, et al. Brain Facts: A Primer on the Brain and 

Nervous System, 2nd ed. Washington, D.C.: Society 

for Neuroscience, 1993.

3 Stouped E, Mirthful J, Rotenberg Z. Admissions of 

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4 Ahern GL, et al. Paraneoplastic temporal lobe epilepsy 

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5 Herzog AG. Temporolimbic epilepsy and polycystic 

ovary syndrome. Fertil Steril 1996;65:210–1.

6 Kimura D, Hampson E. Cognitive pattern in men and

women is influenced by fluctuations in sex hormones.

Curr Direct Psychol Sci 1994;3:57–61. 

7 Halbreich U, et al. Possible acceleration of age effects 

on cognition following menopause. J Psychiatr Res 

1995;29:151–63.

8 Ogata T, et al. Turner syndrome and female sex 

chromosome aberrations: Deduction of the principal 

factors involved in the development of clinical features

[review]. Hum Genet 1995;95:607–29.

9 Prezant TR, et al. Mitochondrial ribosomal RNA 

mutation associated with both antibiotic induced and 

nonsyndromic deafness. Nature Genet 1993;4:289–94.

10 Gerendai I. Neuroendocrine asymmetry [review]. 

Front Neuroendocrinol 1997;18:354–81.

11 Shaywitz SE, et al. Prevalence of reading disabilities in

boys and girls. The Connecticut Longitudinal Study. 

JAMA 1990;264:998–1002.

12 Shaywitz BA, et al. Sex differences in the functional 

organization of the brain for language. Nature 1995 

(Feb. 16);373:607–9. 

13 Rapp P, Amaral D. Individual differences in the 

cognitive and neurological consequences of normal 

aging. Trends Neurosci 1992;15:340–9.

14 McEwen BS, et al. Oestrogens and the structural and 

functional plasticity of neurons: Implications for memory,

aging, and neurodegenerative processes [review]. Ciba

Found Symp 1995;191:52–66; [discussion] 191:66–73.

15 Hampson E, Kimura D. Sex differences and hormonal

influences on cognitive function in humans. In: Becker 

JB, Breedlove SM, and Crews D, eds., Behavioral

Endocrinology. Boston: MIT Press, 1992.

16 Gibbs RB. Estrogen and nerve growth factor-related 

systems in the brain: Effects on basal forebrain cholinergic neurons and implications for learning and 

memory processes and aging [review]. Ann NY Acad 

Sci 1994;743:165–96.

17 McEwen BS, Wooley CS. Estradiol and progesterone 

regulate neuronal structure and synaptic connectivity 

in adults as well as developing brain. Exp Gerontol 1994;

29(3,4):431–6.

18 Wooley CS, McEwen BS. Roles of estradiol and progesterone in regulation of hippocampal dendritic spine 

density during the estrous cycle of the rat. J Comp 

Neurol 1993;336:293–306.

19 Van Cauter E, et al. Effects of gender and age on the 

levels and circadian rhythmicity of plasma cortisol. 

J Clin Endocrinol Metab 1996;81:2468–73.

20 Seeman TE, McEwen BS, Singer BH, Albert MS, Rowe 

JW. Increase in urinary cortisol excretion and memory

declines: MacArthur studies of successful aging. J Clin

Endocrinol Metab 1997;82:2458–65.

21 McEwen BS, et al. Possible mechanisms for atrophy of 

the human hippocampus. Mol Psychiatr 1997;2:255–62.

22 Tuomilehto J, et al. Diabetes mellitus as a risk factor for

death from stroke: Prospective study of the middle-aged

Finnish population. Stroke 1994;27:210–5.

23 White HD, et al. After correction for worse baseline 

characteristics, women treated with thrombolytic therapy

for acute myocardial infarction have the same mortality

and morbidity as men except for a higher incidence of

hemorrhagic stroke. Circulation 1993;88:2097–103.

24 Herzog AG. Continuous bromocriptine therapy in 

menstrual migraine. Neurology 1997;48:101–2.

25 Herzog AG, Klein P, Ransil BJ. Three patterns of 

catamenial epilepsy. Epilepsia 1997;38:1082–8.

26 Pickett CK, et al. Progestin and estrogen reduce sleepdisordered breathing in postmenopausal women. 

J Appl Physiol 1989;4:1656–61.

27 Tarsy D, Thulin PC, Herzog AG. Spasmodic torticollis 

and reproductive function. Movement Disord 1997;12:847. 

28 Tzurio C, et al. Case-control study of migraine and 

risk of ischaemic stroke in young women. Br Med J

1995;310:83.

29 Silberstein SD, and Merriam GR. Estrogens, progestins, and headache [views & reviews]. Neurology

1991;41:786–93.

30 Herzog AG. Progesterone therapy in women with 

complex partial and secondary generalized seizures. 

Neurology 1995;45:1660–2.

31 Taylor DV, et al. Self-injurious behavior within the 

menstrual cycle of women with mental retardation. 

Am J Ment Retard 1993;97:659-64.

32 Longstreth WT, Dennis LK, McGuire VM, Drangsholt MT,

Koepsell TD. Epidemiology of intracranial meningioma.

Cancer 1993;72:639–48.

33 Payami H, et al. Gender difference in apolipoprotein 

E-associated risk for familial Alzheimer disease: A possible

clue to higher incidence of Alzheimer disease in women.

Am J Hum Genet 1996;58:803–11.
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34 Henderson VW, Buckwalter JG. Cognitive deficits of 

men and women with Alzheimer’s disease. Neurology

1994;44:90–6. 

35 Henderson VW, Watt L, Buckwalter JG. Cognitive 

skills associated with estrogen replacement in women 

with Alzheimer’s disease. Psychoneuroendocrinology

1996;21:421–30.

36 Berkley KJ. Sex differences in pain. Behav Brain Sci

1997;20:473–79.

37 Fillingham RB, Maixner W. Gender differences in the response to noxious stimuli. Pain Forum 1995;4:209–21.

38 Unruh AM. Gender variations in clinical pain experience.

Pain 1996;65:123–67.

39 Giamberardino MA, Berkley KJ, Iezzi S, deBigontina P, Vecchiet L. Changes in skin and muscle sensitivity in 

dysmenorrheic vs normal women as a function of body

site and monthly cycle. Soc Neurosci Abstr 1995;21:1638.

40 Hapidou EG, De Catanzaro D. Sensitivity to cold 

pressor pain in dysmenorrheic and non-dysmenorrheic

women as a function of menstrual cycle phase. Pain

1988;34:277–83.

41 Procacci P. Chronobiological studies on pain threshold.

Pain 1993;55:277.

42Touchette N. Estrogen signals a novel route to pain relief. 

J NIH Res 1993;5:53–6.

43 Mojil JS. Identification of sex-specific quantitative trait

locus mediating nonopioid stress-induced analgesia in

female mice. J Neurosci 1997;17:7995–8002. 

44 Medina VM, Dawson-Basoa ME, Gintzler AR. 17 Betaestradiol and progesterone positively modulate spinal

chord dynorphin: Relevance to the analgesia of pregnancy. Neuroendocrinology 1993;58 (3):310–15.

45 Gear RW, Miaskowski C, Gordon NG, Paul SM, Heller 

PH, and Levine JD. Kappa-opioids produce significantly

greater analgesia in women than in men. Nature Med

1996;2:1248–50.

46 Dawson-Basoa MB, Gintzler AR. 17 Beta-estradiol and

progesterone modulate an intrinsic opioid analgesic 

system. Brain Res 1993;601(1–2):241–5.

47 Fix AS, et al. Neuronal vacuolization and necrosis induced

by the noncompetitive N-methyl-d-aspartate (NMDA)

antagonist MK(+)901 (dizocilpine maleate): A light and

electron microscopic evaluation of the rat retrosplenial 

cortex. Exp Neurol 1993;123:204–19.

ORAL HEALTH

“Most of us enter the world head first and throughout our lives our faces are a window to self-image and 

how the world sees us. Yet there is more to the craniofacial

complex than is in the eye of the beholder. Although history

has resulted in differences in training for dentists, physicians and researchers, the body’s nerves, blood vessels,

inflammatory mediators and the like don’t recognize 

artificial demarcations.”*

BACKGROUND

Analyses of recent oral epidemiologic data

from the third National Health and Nutrition

Examination Survey (NHANES III) indicate

that women have shared in the positive oral health

trends for the U.S. population. In fact, at face value

most available oral health statistics are more favorable

for women.1 Thus, why highlight the need for additional research? Two reasons might be that the conditions under study are highly prevalent among both

men and women and that a clustering of oral disease

risk factor variables places significant numbers of

women at high risk for development of oral diseases.

Most oral problems are “complex” diseases in 

that the manifestation of the condition is the result 

of multiple genes and gene susceptibility factors 

interacting with behavioral and environmental variables. A variety of demographic, general health, 

economic, social, and behavioral factors may be 

operative in placing subgroups of women at high 

risk for development of oral diseases. These factors

include extended longevity, experience with multiple

chronic conditions, medications, cognitive impairments, compromised functional status, and physical

confinement. Each of these can induce biological or

behavioral changes that adversely affect oral health.2

The life situations of significant numbers of

women, including their poverty, underinsurance, 

and status as single head of household or family 

caregiver, may make attending to oral health and 

dental treatment needs problematic. Social influences

such as traditional gender-role expectations or low

income may influence women to defer consideration 

of their own oral health status while ensuring the 

well being of others. Gender-role expectations may 

also bear on women’s interactions with dental care

providers, possibly affecting treatment recommendations. Similarly, behavioral patterns on the rise among

women, including increases in smoking, unprotected

sexual activity, and binging and purging, will likely

lead to parallel increases in oral and pharyngeal 

cancers, AIDS-related oral pathologies, and tooth 

erosion and cavities.2

Another reason to consider oral health an 

important issue for women is its association with 

overall health and quality of life. The literature 

indicates that the progressive consequences of oral 

diseases are not only physical but economic, social, 

and psychological.3-13 This point is underscored 

Cochairs

Maryann Redford, D.D.S., M.P.H.

National Institute of Dental Research

National Institutes of Health 

Marjorie Jeffcoat, D.M.D.

University of Alabama at Birmingham

Susan Silverton, M.D., Ph.D.

University of Pennsylvania

Rapporteur: Joanna Fringer, M.A.

135

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*Excerpt from the Oral Health Working Group Presentation: Putting It All Together: Research on Women’s Health for the 21st Century.
136

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

by the frequency with which fiction and drama 

exemplify general pain, suffering, or demise with

depictions of oral problems.14

Because oral problems are typically repetitive 

and cumulative across the life span, disabling and

handicapping outcomes are maximized among people

in the later stages of life. Yet there are many opportunities throughout the life course to prevent oral 

problems and/or mitigate their sequelae. 

In incorporating orofacial issues into the study 

of women’s health, the research community can 

gain a fuller understanding of women’s health needs

and help ensure that oral problems do not unnecessarily add to women’s health and life burdens in 

the 21st century. (See Figures 1 and 2 for background information.)

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

Since its inception in 1990, the Office of 

Research on Women’s Health (ORWH) has worked

with the National Institute of Dental Research (NIDR)

to strengthen and enhance research related to oral 

diseases, disorders, and conditions that affect women.

Collaboration has included the support of several

major conferences, including the 1992 Osteoporosis

and Oral Bone Loss Workshop, the 1995 Workshop 

on Selected Chronic Pain Conditions, and the 1997

Technology Assessment Conference on Management 

of Temporomandibular Disorders.

Similarly, the NIDR and ORWH have joined forces

to support extramural grants and intramural research

projects investigating a wide array of issues of special

FIGURE 1. Content Areas in the Study of Women’s Oral Health

Source: Adapted from Chesney MA, Ozer EM. Women and Health: In Search 

of a Paradigm. Women’s Health Research on Gender, Behavior, and Policy 1995;

1(1):3-26.

Oral Influences on Systemic Health

• Evidence for links between oral

infection and diabetes

Women and the Health Care System

• Treatment decisionmaking

• Over/under utilization of professional services

• Health policy

Systemic Influences on Oral Health

• Longevity

• Multiple chronic conditions

• Medication usage

• Cognitive impairments

• Physical confinement

• Compromised fuctional status

• Postmenopausal bone loss

• HIV

• Diabetes

Gender Influences on Health Risk

• Dental care utilization

• Self care

• Eating disorders

• Unprotected sexual activity

Societal Influences on Women’s Health

• Caregiving • Status as single head of household

• Poverty • Gender role expectations

• Underinsurance • Concern for esthetics

• Access to care • Craniofacial trauma

Oral Diseases Affecting the 

Most Women

• Caries

• Peridontal diseases

Diseases More Common in Women 

than in Men

• TMD, orofacial pain, Sjögren’s

syndrome, salivary gland 

dysfunction, burning mouth, 

alterations in taste, pregnancyassociated oral changes.
137

VOLUME 2

relevance to women. Areas of focus include oral 

conditions that are unique to, more prevalent 

among, manifest differently in, have different risk 

factors for, or contribute significantly to morbidity

among women.

By including an oral health working group in 

the “Beyond Hunt Valley” workshop, ORWH has

afforded women’s health researchers, practitioners, 

and advocates an opportunity to integrate oral 

issues into the broader women’s health agenda. 

Such an integrated, multidisciplinary perspective 

is needed to fully capitalize on the scientific opportunities of the new millennium.

The timing of this opportunity to re-examine 

oral health issues within the context of gender could

not be better. Fifty years of progress spurred on by 

federal investments in craniofacial research have 

paved the way for major advances in the 21st century. Recent advances in the fields of biomaterials, 

biomimetics, and tissue engineering are being 

applied to the development of new dental and 

facial implants, temporomandibular joint (TMJ) 

prostheses, bone matrix substitutes, and artificial 

replicas of calcified tissues, skin, and mucosa.15

Clearly, the predictability of clinical success with 

these procedures may be influenced by gender.

Technological improvements have also sparked 

a renewed interest in using oral biochemical and 

structural markers to describe the risk for, presence,

and outcome of oral and general health conditions.

Taking advantage of the easy access to oral tissues,

researchers are already using saliva as an investigational diagnostic aid and potential monitor of disease

progression. Systemic disorders that affect salivary

gland composition and gland function include

Alzheimer disease, Sjögren’s syndrome, cystic 

fibrosis, diabetes, and diseases of the adrenal 

cortex.16 Saliva is also proving to be an effective 

FIGURE 2. Prevalence of Select Oral Conditions Among Women 18 Years of Age and Older: United States 1988-94.

Sources: National Health and Nutrition Examination Survey III

0

20

40

60

80

0

10

20

30

40

50

46.9

Percent of Women

63.8

67.1

49.5

28.9

Tooth Loss1

Moderate 

Peridontal Disease2 Gingivitis

Gingival

Recession3

1.) Loss of 1 or more teeth excluding 

third molars.

2.) Loss of attachment of 2mm or more.

3.) Gingival recession of 2mm or more.

Teeth that Are Decayed, 

Missing Due to Decay, or Filled

Percent of Teeth

Caries Experience
138

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

tool to monitor levels of hormones and therapeutic

medications, as well as the presence of illicit drugs.17

Despite these positive advances, the extent to which

the oral cavity can be exploited in the study of 

women’s health has yet to be fully realized. 

Oral researchers have begun applying gene 

transfer technologies to the repair of diseased or 

damaged salivary glands and to exploring uses of 

the salivary gland to produce therapeutic drugs 

for delivery into the mouth or into the systemic 

circulation.18-20 Research opportunities abound 

to apply these advances to a myriad of conditions

affecting women. 

A new series of experiments recently published

indicate that female dental patients respond more

favorably than their male counterparts to kappa 

opioid analgesics for control of postoperative pain.21,22

Because most clinically prescribed analgesics are of 

the mu opioid type, including morphine, codeine, 

and percodan, these findings could be used to benefit

the large numbers of women undergoing operative 

procedures. More research is needed to generalize 

these findings to other clinical situations and to 

translate them as appropriate to clinical practice. 

This observed gender difference in postoperative analgesia has added fuel to longstanding conjectures about male and female nervous system 

differences in response to pain. Indeed, studies in 

mice have shown that some quantitative trait loci 

for genes associated with responses to pain and 

analgesia are gender-specific.23-25 These findings 

may help explain why certain painful conditions,

including temporomandibular joint disorders, 

trigeminal neuralgia, fibromyalgia, reflex sympathetic dystrophy, migraine headaches, and burning

mouth, are more commonly reported in women. 

Similarly, new research on gender differences 

in taste perception may shed light on women’s 

greater propensity for some painful conditions.26,27

Oral health scientists have demonstrated that women

are more likely than men to be supertasters to a bitter

compound known as 6-n-propylthiouracil (PROP).28

Supertasters to PROP have more fungiform papillae

than non or medium PROP tasters, and experience

more intense tastes (especially for bitter and sweet),

more intense oral burn (e.g., alcohol, capsaicin), 

and more intense touch sensations from fats in food

(e.g., “creaminess,” “oiliness”).29–31 These findings, 

coupled with the fact that fungiform papillae receive

innervation from the trigeminal nerve, have led to

speculation that taste perception and experiences 

with trigeminal neuralgia and burning mouth may 

be linked.

There is new appreciation for the ways in 

which host factors modulate the susceptibility to 

and pathogenesis of caries and periodontal diseases,

long considered localized infections. For instance, 

preliminary data from an oral ancillary study of the

Women’s Health Initiative indicate significant positive correlations between oral and hip bone mineral

densities.32 These findings indicate that oral bone 

loss caused by periodontal pathogens may be exacerbated by postmenopausal estrogen deficiency. Recent

evidence also indicates that persons with noninsulindependent diabetes mellitus are three times more 

likely to develop periodontal disease than nondiabetic individuals. As diabetes increases in severity, 

the rate at which vital tooth-anchoring bone is lost

accelerates.33,34 Both of these systemic health conditions account for significant morbidity among women;

these recent oral findings suggest that there is more 

to this morbidity than previously considered.

Oral effects of systemic disease are by no means

limited to the periodontium. From birth to death, 

the mouth’s continued exposure to opportunistic 

infectious pathogens is in balance with host immunity. When the host’s immune system is compromised, 

as with HIV infection, certain microbes’ virulence 

and ability to adhere to and colonize oral tissues is

enhanced. Such is the case with C. albicans, whose

overgrowth in the oral cavity highly suggests immune

suppression. In fact, oral candidiasis is the most common opportunistic infection seen in HIV and is often

used to herald the presence of infection and/or to 

indicate disease progression.35,36 NIDR-supported
“An alarming shortage of research-trained, 

full-time female dental faculty exists at our 

dental schools.”

Debra Studen-Pavlovich,

D.M.D.

American Association 

of Dental Schools

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research to characterize the entire genome of C. 

albicans will accelerate progress in other areas 

of candida research including virulence factors, 

drug resistance, genomic evolution, and treatment. 

The information provided by this line of research 

will have considerable bearing on HIV-infected 

and uninfected women’s experiences with oral 

and genital tract fungal infections. Similarly, saliva’s 

known anti-HIV activity and the intense search 

to identify protective salivary constituents may 

ultimately be applied to the formulation of new 

topical microbicides. In fact, all of oral HIV research,

particularly in the areas of opportunistic infections,

mucosal immunity, synthetic drugs and vaccines, 

and innovative drug delivery systems have tremendous potential to benefit women in that they are 

the fastest growing population with AIDS. 

In this new scientific era, there are many reasons

to consider oral and general health interactions as 

bi-directional. In the case of diabetes, new evidence

points to chronic periodontal disease as a disrupter 

of glucose control, possibly due to induction of insulin

resistance.37 Perhaps even more surprising is preliminary evidence implicating periodontal disease as an

independent risk factor for myocardial infarction and

stroke. Epidemiologic findings indicate a nearly twofold risk for fatal myocardial infarction and stroke for

persons with established periodontal disease.38 More

research is needed, including of a mechanistic nature,

to further substantiate these findings. Future research

in both the diabetes and heart disease/stroke arena

should include greater numbers of women and 

examine potential gender differences in systemic

responses to treating oral infections.

Furthermore, the impact of oral infections on 

the lives of women may relate not only to their 

own health but also to that of their offspring. Recent

studies of microbial colonization between spouses 

and between parents and children have demonstrated

that oral pathogens are transmitted among members 

of extended families.39,40 Perhaps even more surprising is emerging evidence that poor maternal 

periodontal health increases an infant’s potential 

for low birthweight and for preterm or premature

birth. Recent findings indicate that severe periodontal disease in pregnant women is linked to 

a sevenfold increase in the risk of delivering preterm low-birthweight babies. It is estimated that 

as many as 18 percent of the 250,000 premature 

low-birthweight deliveries in the United States each

year may be attributed to infectious oral disease.41,42

Scientists working in this area theorize that oral

pathogens release toxins that reach the human placenta via the mother’s blood circulation, as shown 

by results from animal studies. Additional research 

is needed to substantiate this hypothesis and to 

confirm this intriguing link. 

With remarkable advances in science and 

technology have come increased responsibilities 

to ensure an adequate supply of competent investigators in the years to come. Education of dental 

care providers is an increasingly expensive endeavor 

for the school and for the individual. In 1996, the 

average accumulated debt of a graduating dental 

student was more than $81,000. This debt is a significant deterrent to continuing studies by the dental

school graduate, including research training. Furthermore, research training is not part of the undergraduate dental school curriculum nor is it included in 

dental residency programs. As a consequence, dental

graduates are not generally exposed to research and 

are not oriented to pursuing advanced research 

training. In the case of female dental students, the 

situation is further compounded by a lack of role 

models. Women are underrepresented at all levels 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

of academic dentistry; only 15 percent of associate 

professors and 5 percent of full professors are women.

These figures are significantly lower than those in 

the academic medical environment, where twice as

many women are at the full professor level. The result

of these circumstances is a dearth of women in academics and research. Continued support and enhancement of oral research training and career development

programs are needed to help ensure that women can

assume leadership roles in academic and health professional institutions, government agencies, and 

the private sector. 

GAPS IN KNOWLEDGE

Large gaps in knowledge limit the ability to 

interpret oral health within the context of gender. 

For instance, there are areas in which oral health 

information for either gender, even at the descriptive

level, is partial or nonexistent. Data gaps in the areas 

of craniofacial trauma, soft tissue pathologies, and 

salivary gland dysfunctions are notable illustrations. 

Even in the presence of descriptive data, the 

lack of knowledge about etiologic factors, mechanisms, and clinical course of oral diseases limits the 

utility of available oral health statistics. For example,

women are reported to be more inclined to self care,

more likely to visit a dentist, and more likely to report

symptoms such as pain. The degree to which these

behaviors influence oral disease patterns is unknown.

Similarly, there is a dearth of information on the 

influence of gender on dental treatment decisionmaking and care delivery. Is women’s oral health 

status a reflection of primary disease experience 

or gender-specific treatment patterns?2

In addition, large gaps in knowledge limit the 

ability to translate scientific advances to improvements in health. As previously mentioned, breakthrough discoveries in the areas of biomimetics, 

biomarkers, gene transfer technologies, and pain

research have paved the way for a myriad of clinical applications. More research is needed to clarify 

the influence of gender on the predictability of 

clinical success for new procedures and pharmacologic regimens. 

Although progress has been made in recognizing

some oral and general health interactions, considerable

research is needed to confirm putative associations 

for both genders and uncover biologic bases for these

links. Additional research is also needed to determine

whether there are gender differences in responses to

therapies for the oral and general health conditions

involved in these links. 

RESEARCH 

RECOMMENDATIONS 

Although the oral health research community 

can exult in its many recent successes, new-found

knowledge challenges all of us to do more. It is 

within this context that oral health working group

members encourage additional research in all the 

areas of oral health study discussed in this report. 

The bulleted list below highlights research areas

that are particularly ripe for study and that have the

greatest capacity to control oral diseases and improve

the general health and quality of life of women.

Biomimetics

• Study the effect of hormonal status on the 

efficacy of guided bone and tissue engineering procedures.

Diagnostic Markers

• Investigate the utility of saliva as a matrix 

for studying biological markers important 

to women’s health and diseases.

• Determine how best to utilize oral examination

findings and the dental clinic encounter in 

domestic violence, child abuse, and eating 

disorders intervention programs.

• Explore whether dental radiographs can 

be useful in identifying aberrant skeletal 

bone changes.
“. . . Sjögren’s syndrome affects women 

primarily, and women’s health problems, especially

problems occurring in middle-aged women, have 

been notoriously understudied.”

Evelyn J. Bromet, Ph.D.

Sjögren’s Syndrome 

Foundation, Inc.

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VOLUME 2

Sjögren’s Syndrome and Autoimmune Diseases

• Investigate the role of gender in autoimmune 

conditions, including the role of sex hormones in induction and perpetuation of 

these conditions.

• Study gender-controlled transcription 

differences that influence autoimmune 

disease penetrance. 

• Conduct research on the impact of hormonal 

therapy on women with Sjögren’s syndrome 

and other autoimmune conditions.

• Identify appropriate and sensitive clinical 

outcome measures for the exocrine dysfunctions associated with Sjögren’s syndrome. 

• Conduct controlled clinical trials testing new 

biological therapies for Sjögren’s syndrome.

Pain

• Study the relations among fluctuations 

in reproductive hormones and pain experiences including cognitive, emotional, and 

behavioral components.

• Investigate the hormonal influences on 

nociception and pain modulation pathways, 

and investigate the effects of replacement 

therapies on pain and analgesia.

• Examine women’s stress response to pain 

and coping behaviors. 

• Study sociocultural effects on women’s 

responses to pain across the life span and 

in different cultural milieus.

• Examine predictors of chronic pain development in women, including diminished activation of endogenous pain control systems.

• Conduct basic research to examine the effects 

of estrogens and other hormones on nociception and pain modulation pathways.

• Study the interactions between oral taste 

and pain sensations, particularly as they 

relate to painful oral lesions and oral pain 

in the absence of visible oral pathology, 

as in burning mouth syndrome.

• Explore the mechanisms and models (both 

animal and human) underlying gender differences in response to noxious stimuli and 

analgesic medications.

• Study the role of genomic and nongenomic 

mechanisms mediating actions of gonadal hormones on pain perception and 

pain control. 

• Investigate the role of steroid hormone 

response elements in regulation of gene 

expression in pain pathways.

Temporomandibular Disorders

• Conduct studies to elucidate the etiology 

and pathogenesis of TMDs, including 

the contributions of segmental versus 

heterosegmental hyperalgesia to TMD 

myogenous pain. 

• Design evidence-based research studies 

to determine optimal treatments and outcomes for specific TMD clinical presentations.
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

HIV

• Investigate the prevalence of oral lesions 

among infected women and determine 

their prognostic significance for HIV 

disease progression. 

• Determine if there are gender differences 

in response to, and compliance with, oral 

lesion therapies.

• Explore the relation between oral and 

vaginal candidiasis and study the effects 

of oral versus systemic antifungal therapies 

on oral candidal lesions. 

• Determine the relationship of oral diseases 

in HIV-infected women and their children, 

including perinatal transmission.

• Investigate the barriers to accessing oral care 

for HIV-infected women and evaluate the 

resultant effects on health and oral health.

Interrelationships of Oral and Systemic Disorders 

Osteoporosis

• Study the relationship of periodontal disease, 

alveolar bone loss, residual ridge resorption,

osteopenia, and osteoporosis.

• Explore how stress, coping behaviors, and 

depression modify the relationship among 

oral bone loss, osteopenia, and osteoporosis.

• Determine whether bone density in the 

oral cavity correlates with systemic bone 

mineral density.

• Determine if common therapeutic strategies 

can be exploited for treating alveolar bone 

loss and systemic bone loss.

• Determine the influence of hormonal 

status and hormone replacement therapy 

on oral bone loss and tooth retention.

Diabetes

• Determine the role of periodontal infection 

as an aggravating factor for diabetes mellitus 

in women. 

Cardiovascular Disease 

• Study periodontal infection as a risk for 

CVD in women.

Spontaneous Preterm Births

• Study fundamental mechanisms that combine 

oral disease measures and microbial, immunological, and inflammatory parameters to understand how oral infection may modify the 

maternal-fetal interaction.

• Conduct population-based, prospective studies 

to assess the independent contribution of periodontal infection to the risk of spontaneous

preterm birth (SPB).

• Carry out intervention studies to determine

whether periodontal therapy reduces the 

incidence or morbidity associated with SPB.

• Expand animal studies on the underlying 

mechanisms of SPB and the influence of 

distant infection on pregnancy.

Dental Education, Research, and Training

• Establish mentoring programs for girls to 

encourage them to pursue science courses 

and careers, including programs linking 

high schools to universities.

• Expand short-term research opportunities 

for female undergraduate dental students 

to stimulate interest in research careers.

• Develop research training programs targeted for women with the capacity to 

accommodate the increasing pool of 

women dental graduates.
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VOLUME 2

• Develop clinical research training programs 

targeted for women as part of advanced 

primary care dental education programs.

• Continue to provide supplemental research 

training and funding opportunities to women 

who must often interrupt their careers because 

of family care responsibilities.

References

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10 Kressin NR. The oral health-related quality of life 

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14 Gift HC, Redford M. Oral health and quality of life. 

Clin Geriatr Med 1992;8:673-84.

15 Slavkin HC. Biomimetics: Replacing body parts 

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16 Atkinson JC, Fox PC. Salivary gland dysfunction. 

Clin Geriatr Med 1992;8:499-511.

17 Malamud D, Tabak L, eds. Saliva as a diagnostic fluid. 

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18 Mastrangeli A, O’Connell B, Aladib W, Fox PC, Baum BJ,

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19 Delporte C, O’Connell BC, He X, Lancaster HE, 

O’Connell AC, Agre P, Baum BJ. Increased fluid 

secretion after adenoviral-mediated transfer of the 

aquaporin-1 cDNA to irradiated rat salivary glands. 

Med Sci 1997;94:3268-73.

20 Adesanya MR, Redman RS, Baum BJ, O’Connell BC.

Immediate inflammatory responses to adenovirusmediated gene transfer in rat salivary glands. Hum 

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21 Gear RW, Miaskowski C, Gordon NC, Paul SM, Heller 

PH, Levine JD. Kappa-opioids produce significantly 

greater analgesia in women than in men. Nat Med

1996;2:1248-50.

22 Gear WG, Gordon NC, Heller PH, Paul S, Miaskowski C,

Levine JD. Gender difference in analgesia response to the

kappa-opioid pentazocine. Neurosci Lett 1996;205:207-9.

23 Mogil JS, Kest B, Sadowski B, Belknap JK. Differential

genetic mediation of sensitivity to morphine in genetic

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24 Mogil JS, Marek P, Flodman P, Spencer MA, Sternberg WF,

Kest B, Sadowski B, Liebeskind JC. One or two genetic 

loci mediate high opiate analgesia in selectively bred 

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25 Mogil JS, Richards SP, O’Toole LA, Helms ML, Mitchell SR,

Belknap JK. Genetic sensitivity to hot-plate nociception 

in DBA/2J and C57BL/6J inbred mouse strains: possible

sex-specific mediation by 2-opioid receptors. Pain

1997;70:267-77.

26 Bartoshuk LM, Duffy VB, Fast K, Garvin V, Lucchina L,

Rodlin J, Snyder D, Streigel-Moore R. Variability in taste,

oral pain, and taste anatomy: Evidence for menstrual 

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27 Bartoshuk LM, et al. Do taste-trigeminal interactions 

play a role in oral pain? Chem Senses 1996;21:578.

28 Bartoshuk LM, Duffy VB Miller IJ. PTC/PROP tasting:

Anatomy, psychophysics, and sex effects. Physiol Behav

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29 Bartoshuk LM, Fast K, Karrer TA, Marino S, Price RA,

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30 Duffy VB, Bartoshuk LM, Lucchina LA, Snyder DJ, 

Tym A. Supertasters of PROP (6-n-propylthiouracil) 

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Chem Senses 1996;21:598.

31 Tepper BJ, Nurse RJ. Fat perception is related to 

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32 Jeffcoat MK, Lewis CE, Reddy MS, Wang CY, Redford M.

Post-menopausal bone loss and its relationship to oral

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1993;2:98-116.

34 Gossi SG, Skrepcinski FB, DeCaro T, Zambon JJ, Cummins

D, Genco RJ. Response to periodontal therapy in diabetes

and smokers. J Periodontol 1996;57:1094-102.

35 Shiboski CH, Hilton JF, Greenspan D, Westenhouse JL,

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Cohen JB, Moss AR, Greenspan JS. HIV-related oral manifestations in two cohorts of women in San Francisco. AIDS

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36 Shiboski CH, Hilton JF, Neuhaus JM, Canchola AJ,

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and gender: A longitudinal analysis. Arch Intern Med

1996;156:2249-54.

37 Taylor GW, Burt BA, Becker MP, Genco RJ, Glossman 

M, Knowler WC, Pettitt DJ. Severe periodontitis and 

risk for poor glycemic control in patients with noninsulin-dependent diabetes mellitus. J Periodontal 1996

(Suppl);67:1085-93.

38 Beck J, Garcia R, Heiss G, Vokonas PS, Offenbacher S.

Periodontal disease and cardiovascular disease. 

J Periodontol 1996;67(Suppl):1123-37.

39 Tuite-McDonnell M, et al. Concordance of Porphyromonas gingivalis colonization in families. J Clin Microbiol

1997;35(2):455-61.

40 Li Y, Caufield PW. The fidelity of initial acquisition of

Mutans streptococci by infants from their mothers. 

J Dent Res 1995;74(2):681-5.

41 Offenbach S, et al. Periodontal infection as a possible 

risk factor for preterm low birth weight. J Periodontol

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42 Dasanayake AP. Pregnant women’s poor health and 

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Additional References

Tissue Engineering

Alper J, Gibbs WW. Boning up: Newly isolated proteins 

heal bad breaks [news]. Published erratum appears in 

Science 1994 Mar 11;263(5152):1359.

Bruder SP, Fink DJ, et al. Mesenchymal stem cells in 

bone development, bone repair, and skeletal regeneration 

therapy. J Cell Biochem 1994;56(3):283-94.

Goldberg VM, Caplan AL. Biological resurfacing: 

An alternative to total joint arthroplasty. Orthopaedics

1994;7(9):819-21.

Saliva Diagnostics

Marder MZ, Joshi U, Mandel LD. Estrogen concentration 

in human parotid and submaxillary saliva. J Dent Res

1979;58(12):2370.

Mounib N, Sultan C, Bringer C, Hedon B, Nicolas JP, Cristol 

P, Bressot N, Descomps B. Correlations between free plasma

estradiol and estrogens determined by bioluminescence in saliva, plasma, and urine during spontaneous and FSH stimulated

cycles in women. J Steroid Biochem 1988;31(5):861-5.

Pain and Analgesia

Berkley KJ. Female vulnerability to pain and the strength to 

deal with it. Behav Brain Sci. In press.

Bodnar RJ, Romero M, Kramer E. Organismic variables and

pain inhibition: Roles of gender and aging. Brain Res Bull

1988;21:947-9.
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Carlsson G, LeResche L. Epidemiology of temporomandibular disorders. In: Sessle B, Bryant P, Dionne R, eds. Progress 

in pain research and management. Seattle: IASP Press, 1995, 

pp. 211-26.

Cicero TJ, Nock B, Meyer ER. Gender-related differences in 

the antinociceptive properties of morphine. J Pharmacol Exp

Ther 1996;279:767-73.

Cogan R, Spinnato JA. Pain and discomfort thresholds in 

late pregnancy. Pain 1986;27:63-8.

Dawson-Basoa ME, Gintzler AR. Estrogen and progesterone

activate spinal kappa-opiate receptor analgesic mechanisms.

Pain 1996;64:607-15.

Dao TTT, Knight K, Tenenbaum HC, Lue F, Ton-That V. 

Influence of oral contraceptives on the fluctuations of 

myofascial pain over three consecutive menstrual cycles: 

A preliminary report. Abstracts, 8th World Congress on 

Pain. Seattle: IASP Press, 1996, p. 278.40.

Dworkin SF, Huggins KH, LeResche L, Von Korff M, Howard J,

Truelove E, Sommers E. Epidemiology of signs and symptoms

in temporomandibular disorders: Clinical signs in cases and

controls. J Am Dent Assoc 1990;120:273-81.

Fillingim RB, Maixner W. Gender differences in the responses 

to noxious stimuli. Pain Forum 1995;4:209-21.

Gintzler AR. Endorphin-mediated increases in pain 

threshold during pregnancy. Science 1980;210:193-5.

Goulet JP, Lavigne GJ, Lund JP. Jaw pain prevalence among

French-speaking Canadians in Quebec and related symptoms 

of temporomandibular disorders. J Dent Res 1995;74:1738-44.

LeResche L, Saunders K, Von Korff M, Barlow W, Dworkin SF.

Use of exogenous hormones and risk of temporomandibular

disorder pain. Pain 1997;69:153-60.

LeResche L. Epidemiology of temporomandibular disorders:

Implications for the investigation of etiologic factors. Crit Rev

Oral Biol Med 1997;8:291-305.

Lipton JA, Ship JA, Larach-Robinson D. Estimated prevalence

and distribution of reported orofacial pain in the United States.

J Am Dent Assoc 1993;124:115-21.

Locker D, Slade G. Prevalence of symptoms associated with

temporomandibular disorders in a Canadian population. 

Community Dent Oral Epidemiol 1988;16:310-3.

Marcus DA. Clinical review: Interrelationships of neurochemicals, estrogen, and recurring headache. Pain 1995;62:129-39.

Sander HW, Kream RM, Gintzler AR. Spinal dynorphin 

involvement in the analgesia of pregnancy: Effects of intrathecal dynorphin antisera. Eur J Pharmacol 1989;159:205-9.

Silberstein SD, Merriam GR. Estrogens, progestins, and

headache. Neurology 1991;41:786-93.

Spagnoli D, Kent JN. Multicenter evaluation of temporomandibular joint proplast-teflon disk implant. Oral Surg

Oral Med Oral Pathol 1992;411-21.

Von Korff M, Dworkin S, LeResche L. Graded chronic pain 

status: An epidemiologic evaluation. Pain 1990;40:279-91.

Unruh AM. Gender variations in clinical pain experience. 

Pain 1996;65:123-67. Science 1980;210:193-5. 

Oral Bone

AAP. Glossary of periodontic terms. J Periodontal 1986;

Supplement:1-31.

Jeffcoat MK, Chesnut C. Systemic osteoporosis and oral 

bone loss. J Am Dent Assoc 1993;124:49-56.

Nakagawa S, Fujii H, Machida Y, Okuda K. A longitudinal

study from prepuberty to puberty of gingivitis. Correlation

between the occurrence of Prevotella intermedia and sex 

hormones. J Clin Periodontol 1994 Nov;21(10):658-65.

Sooriyamoorthy M, Gower DB. Hormonal influences on 

gingival tissue: Relationship to periodontal disease. J Clin 

Periodontal 1989;16(4):201-8.

Zachariasen R. Oral manifestations of metabolic bone disease:

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Zachariasen RD. The effect of elevated ovarian hormones 

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Women’s Health 1993;20(2):21-30.

PHARMACOLOGIC ISSUES

BACKGROUND

This meeting marked the first time that 

pharmacology has been addressed in a formal

working group of the “Beyond Hunt Valley”

series of meetings held between September 1996 and

November 1997. The recognition of pharmacology 

as a separate topic is a result of discussions held 

during three regional meetings (Philadelphia, New

Orleans, and Santa Fe), where there was repeated

emphasis on the importance of research to (a) elucidate how pharmacologic agents are handled in 

women throughout the life span and in different 

racial and ethnic groups (possible pharmacokinetic 

and pharmacogenetic variations) and (b) determine

how the female body is affected by specific agents,

alone or in combination (pharmacokinetic and pharmacodynamic variations). The importance of preclinical information to elucidate mechanisms of diseases

important to women was extended to elaborating 

on pharmacologic mechanisms as well.

In approaching discussions about pharmacologic issues, the working group incorporated an 

interdisciplinary approach to the gender framework 

for health research.1-3 This approach encompasses

knowledge from varied disciplines such as medicine,

nursing, pharmacy, and the basic sciences of molecular biology, genetics, public health, epidemiology,

anthropology, agriculture, health education, and 

sociology. This framework takes into account economic, social, personal, as well as biologic characteristics of individuals.

This report deals with pharmacologic agents, 

gender-based differences in response and possible 

variations during a woman’s life span. For the purposes of this report and for research agenda planning, pharmacologic agents are defined as traditional

therapeutic drugs and biologics, dietary supplements

(vitamins and minerals), and alternative medicines.

However, the majority of this chapter reflects information regarding traditional therapeutic drugs.

Two terms used frequently throughout this 

report are pharmacokinetics (PK) and pharmacodynamics (PD). They bear definition at this point.

• Pharmacokinetics. PK encompasses the study 

of the rate and extent of drug absorption, distribution, metabolism, and excretion. It is used 

to relate the dose of a drug to the concentration 

of the drug in the blood as a function of time. 

Thus any physiological process that influences 

the PK of a drug and is functionally different

between the genders will contribute to genderrelated differences in drug response.

• Pharmacodynamics. PD encompasses the study 

of the rate and extent of drug response and is 

used to relate the concentration of drug in the

blood to the extent of pharmacological response.

Thus for any given concentration of drug in the

blood, if a drug receptor has gender-related differences in sensitivity, the drug may elicit genderrelated differences in drug response including 

differential efficacy or safety of the drug.

Cochairs

Mary J. Berg, Pharm.D.

University of Iowa, College of Pharmacy

Jeanne N. Ketley, Ph.D.

Cardiovascular Sciences Initial Review Group

National Institutes of Health

Ruth Merkatz, Ph.D.

Women’s Health, Pfizer, Inc.

Rapporteur: Abraham Mittelman, M.P.H.

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SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT 

OF ORWH

Since the Hunt Valley meeting in 1991, extensive progress has been made in advancing the understanding of issues and in describing gaps in our 

knowledge that need to be examined. First and foremost is the progress made in promoting participation

of women, including women of childbearing potential,

in all phases of clinical trials to acquire more scientific

information on how drugs work in women. In 1993,

the Food and Drug Administration (FDA) published

the “Guideline for Study and Evaluation of Gender 

Differences in the Clinical Evaluation of Drugs,” 

which lifted the ban on including these women in 

early phases of drug studies and called for analysis 

of data for gender effects in all new drug applications

submitted to FDA. In 1994, the National Institutes 

of Health (NIH) published its NIH Guidelines on 

Inclusion of Women and Minorities as Subjects in 

Clinical Research. 

We are much more aware today than we were 

in 1991 of the clinically significant PD differences 

in drug-induced responses between men and women.

For example, women have a heightened sensitivity to

developing cardiac rhythm disorder upon exposure 

to a number of agents, including common antiarrhythmics and antihistamines.4-9 This potential hypersusceptibility of women underscores the need to perform

additional research on the mechanisms of genderspecific adverse drug events.

Advances in Understanding Mechanisms of 

Drug Action

Progress has been made in identifying and 

understanding factors related to mechanisms of drug

action such as the role of various metabolic enzymes.

There has been elaboration of the cytochrome P450

(CYP 450) isoenzymes and the role of hormonal 

variation in drug effects. For example, the participants of a 1995 conference sponsored by the FDA 

recommended that in cases where metabolism of 

a drug occurs primarily through CYP 450 1A2 or 

3A4, PK differences due to hormonal effects are 

more likely, and this influence should be examined 

in early drug testing. 

At that same conference it was suggested 

that PD differences between men and women, 

as well as PK differences, were important to study,

because PD predicts clinically important safety 

and efficacy effects more accurately than PK. It was 

also recognized that PK differences do not always 

translate into clinically significant PD differences. 

Similarly, PD differences may occur without noted 

PK differences. Figure 1 provides a drug development approach that emerged at that conference for 

uncovering clinically important gender differences.10

Few drugs have undergone gender analysis.11

Progress has also been made in identifying mechanisms of drug action, such as enzyme activity 

(for an overview of current understanding of 

factors influencing gender-based PK and PD, 

see Harris et al., 1995).12

Understanding Hormonal Impacts

NIH has embarked upon extensive study of 

the changing hormonal milieu in postmenopausal

women in relation to their overall health and the

occurrence of certain diseases. The results of the 

Postmenopausal Estrogen/Progesterone Intervention

(PEPI) trial provide surrogate endpoint information

(e.g., lipid levels) regarding cardioprotective effects 

of current hormonal preparations. The Women’s 

Health Initiative (WHI), when complete, is expected 

to yield vital information about cardiac events, bone

integrity, incidence of certain cancers, and Alzheimer

disease. Major research efforts have been undertaken 

to identify and assess impacts on various estrogen

receptors such as those in the heart, brain, blood 

vessels, genito-urinary system, and skin and the 

influence of such receptors on PD variation. Much

more research progress is expected as newer forms 

of hormone-analog molecules such as the selective

estrogen receptor modulators enter clinical investigation and the marketplace.
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Clinical Practice

Studies advancing the understanding of PK/PD

gender issues have begun to generate an understanding of the differences in clinical effects. For example, 

a study published in 1996 showed that a class of 

opiate drugs were more effective in women than 

men following dental surgery.13 It has been shown 

that the menstrual cycle changes the PK of only a 

few commonly prescribed medications.13 Treatment 

of women with HIV has sparked research interest in

the relationship between new antiviral agents and

FIGURE 1. Gender Studies

PK and/or PD studies for

gender effects in phase

1 and 2 studies

• Prior information • Critical/lifesaving

• Intended use • Routes of elimination 

• Narrow therapeutic index drugs • Others

• Non-clinical studies

Signal of Gender Effect?

Safety and Efficacy Gender Subset Analyses

Targeted PK and/or PD

studies to confirm gender effect

• Go to phase 2B/phase 3 clinical trials

• Do prospectively designed population PK/PD gender effect?

• Conduct appropriately

designed phase 2B or

phase 3 clinical trials 

with appropriate

dosing

• Conduct ordinary

phase 2B/phase 3

clinical trials

• No different doses

between genders

Unexpected Confirmed

Findings

Additional

Studies?

Yes

Yes Yes

No

No No
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

effects on menstrual cycles. Similarly, principal 

investigators have begun to address questions about

menstrual cycle effects while conducting clinical 

trials to evaluate specific drug effects on women. 

Significant advances have also been made in recognizing the importance of adverse effects occurring 

during drug therapy and/or following ingestion of

dietary supplements.

GAPS IN KNOWLEDGE

Despite the impressive advances in policies 

regarding the participation of women as subjects 

in research and analysis of data for gender effects, 

gaps in our knowledge remain regarding the behavior of drugs in women. Areas where much additional research is needed include mechanisms 

of drug action, which include PK, PD, pharmacogenetics; biological/molecular basis of pharmacological effects such as ion channels and membrane

transporters; chronopharmacology; and modulators

such as sex steroid hormones that can influence 

PK and receptor sensitivity in target end organs. 

Similarly, progress is also needed for analysis of 

data by sex.

Research is also needed in identification and 

quantification of risks associated with use of pharmacologic agents at different points in the life span.

For example, there are major gaps in our knowledge 

of basic mechanisms of action for drugs taken by 

pregnant women. Long-term safety data of therapeutic agents in regard to fetal outcome are also 

lacking. Studies are needed to explore the interaction of drugs that have parallel metabolic pathways

with exogenous hormones (hormonal contraceptives

and hormone replacement therapy). 

Components of Pharmacologic Effects 

Recent reviews describe the status of genderbased PK and PD research.11,12 Although significant research advances have been made, the gaps 

in our knowledge base in this area represent a 

serious impediment to understanding and assessing the benefits and risks of both current and 

proposed clinical interventions during a woman’s 

life cycle. Research is needed to evaluate the altered 

susceptibility to pharmacological agents throughout 

the life span with special issues pertinent to:

• Children

• Adolescents

• Women with childbearing potential 

• Pregnant women

• Lactating women

• Perimenopausal women

• Postmenopausal women 

• Senior women

Although gender differences have long been

observed in many areas of biology, until relatively

recently it has not been appreciated that these 

differences may contribute to the variability of 

drug response in humans. However, it is becoming

increasingly clear that males and females have differences in drug response (traditionally thought to 

be related to changes in body mass, body fat, and 

muscle mass), for both PK and PD reasons. For 

example, fluvoxamine plasma concentrations are 

40 to 50 percent lower in men than women, but the

mechanism underlying this difference is unknown 

and gender-based PD data are not available.14 In 

a drug interaction study, isradipine was shown to 

significantly decrease the area under the curve 

(AUC) of lovastatin in male but not female subjects.15 A systematic study of the mechanisms 

for such gender-related variability in drug response 

has yet to be undertaken. Nor is there presently 

any systematic requirement to carry out PD studies

whenever gender-related PK variability is observed.

Pharmacogenetics. Pharmacogenetics is defined 

as hereditary variations in response to drugs,16 where

the majority of variability is caused by alteration in 

the functional activity of metabolic enzymes. The 

study of polymorphism (i.e., capacity to exist in 
“To provide optimal pharmaceutical care, 

pharmacists should be aware of the ethnic and racial

composition of their patient populations, and the 

distinctive characteristics that may elicit ethnic and

racial differences in pharmacologic responses to 

medicines as well as the psychosocial and economic

parameters that influence drug use or misuse.”

Gloria J. Nichols, M.Ed., Ph.D.

Catherine A. White, Ph.D.

University of Georgia

College of Pharmacy

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VOLUME 2

many forms) of genes and their proteins (including

enzymes involved in drug metabolism) is a rapidly

expanding field. Families of enzymes including

cytochrome P450s, UDP glycosyltransferases, sulfotransferases, and N-acetyltransferases catalyze a 

large number of metabolic reactions. Gender differences in the metabolism of certain drugs metabolized by specific isozymes of P450 have been found.17

However, for the most part gender differences in 

the amount of the enzymes are not well defined 

in vitro.18,19

Genetic differences in the activity of enzymes 

have been demonstrated for N-acetyltransferases 

and the cytochrome P450 isozymes, CYP 2D6 and 

CYP 2C19.20-22 There are definite ethnic and racial 

differences in the genetic polymorphism found. For

example, although 5 to 10 percent of whites lack 

CYP 2D6, less than 2 percent of Asians and blacks 

are deficient. Similarly, CYP 2C19 deficiency occurs 

in 15 to 25 percent of Asians, but in only 2 to 5 percent of whites and blacks. However, there are few 

data available regarding the interaction between gender

and genetic polymorphism. Only a few of the studies

that have both (a) measured the incidence of genetic

polymorphism and (b) also specifically mentioned 

the inclu-sion women in the study population have

analyzed the data based on gender. For example, a

review of the literature on the polymorphism of CYP

2C19 is given in Table 1. Of the 38 studies evaluated,

only nine studies performed any type of gender analysis and only six studies provided these data. In two 

of the studies, the incidence of the poor metabolizer 

phenotype/genotype was numerically smaller in 

women than in men; in a single study, the incidence

was higher in women than in men, and in two studies 

no difference was noted. However, as demonstrated 

by Evans et al.,23 the gender effect may be race dependent. In Saudi Arabian women, the incidence of CYP

2C19 deficiency tended to be greater, and in Filipino

women the incidence tended to be lower. Based on

these studies, it appears that CYP 2C19 genetic polymorphism may not be strongly influenced by gender.

This conclusion must be tempered, however, with 

the possibility that all the studies cited may have

lacked the necessary statistical power to determine 

gender differences. 

If most drugs had been developed in mixedgender populations then the extent to which these

issues contribute to gender-related variability in 

drug response would be clearer. However, women 

were systematically excluded from many clinical 

trials until relatively recently, and gender-related 

differences in drug response have only been 

sporadically reported. 

On the other hand, there is some evidence 

that the biological mechanisms that contribute to 

PK and PD of drugs have gender-related differences.

For example, among the P450 drug-metabolizing

enzymes, women have been reported to express 

higher levels of CYP3A24,25 and lower levels of 

the several other P450 isozymes than do men,24

although with sparteine as a marker, there was 

reported to be no effect of gender on CYP 2D6

activity.26 In another study in which 300 mg of 

oral caffeine were administered, female subjects 

exhibited significant toxic effects. These women 

had markedly lower N-demethylation indices as 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

TABLE 1. Inclusion of Women in Population Studies of CYP2C19 Incidence of Poor Metabolizers

# of Subjects Gender Analysis Results: Incidence of Poor Results: CYP2C19 Activity 

Reference Race (Female/Total) of Polymorphism Metabolizers in Females vs. Males in Females vs. Males

Wedlund 198465 Caucasian 7/156 NO

Kupfer 198466 Swiss 127/221 YES Females less than Males 5/127 (3.9%) vs.

7/94 (7.5%) N.S.

Nakamura 198567 Japanese 14/100 NO

Caucasian 14/83

Jurima 198568 Caucasian 127/221 YES Females greater than Males 9/87 (10%) 

Japanese 12/31 but did not females vs. 5/101 (5%) males

Chinese 16/39 separate by race

Jacqz 198969 French Caucasian 74/132 NO

Sanz 198970 Swedish 139/253 NO

Drohse 198971 Danish 136/358 YES No difference; 3% in females, 2.2% in males

Horai 198972 Chinese 26/98 NO

Japanese 114/200

Guttendorf 199073 Caucasian NG/519 NO

Sohn 199274 Korean 50/206 YES Incidence of PM was lower in females 4/50 (8%)

vs. 4/177 (2.226%) but N.S.

Bertilsson 199276 Swedish NG/137 NO

Chinese NG/488

Llerena 199376 Spanish patients 13/72 NO

Spanish ‘normas’ 26/54

Kiivet 199377 Estonians 101/156 NO

Revirigo78 Spanish 196/373 YES Incidence of PM is lower in females 1/196 (0.51%)

Chinese NG/488 vs. 4/177 (2.226%) but N.S.

Weerasuriya 199479 Sinhalese NG/111 NO

Setiabudya 199480 Indonesian 25/104 NO

Basci 199481 Turkish 1/109 NO

Hadidi 199582 Jordanian 36/194 NO

Chang 199583 Swedish 88/160 NO

de Moralis 199584 Chinese NG/244 NO Lower S/R ratio in women

indicating higher CYP2C19
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well as lower levels of CYP1A2.27 Women also 

apparently express lower levels of glucuronyltransferases.24,26 However, among the other families of

drug-metabolizing enzymes, including the sulfotransferases and the glutathione-S-transferases, 

less is known. 

TABLE 1. Inclusion of Women in Population Studies of CYP2C19 Incidence of Poor Metabolizers

# of Subjects Gender Analysis Results: Incidence of Poor Results: CYP2C19 Activity 

Reference Race (Female/Total) of Polymorphism Metabolizers in Females vs. Males in Females vs. Males

Brockmoller 199585 German 62/174 YES No gender effect, No data given

Masimirembwa 199586 Black Shona NG/103 NO

Balian 199587 Mixed 64/142 NO

Evans 199523 Saudi Arabian 10/102 YES 1/10 (10%) vs. 1/92 (1%) 2/17 (12%) No gender difference

Filipino 17/55 vs. 11/38 (29%) Female vs. male in either group

Marinac 199688 Black 71/99 YES No gender effect

Kubota 199689 Japanese 85/186 NO

Edeki 199690 Black 97/191 NO Higher S/R ratio indicating

lower CYP2C19 in women

Jurima-Romet 199691 Canadian Inuit 57/152 NO

Takakubo 199692 Japanese NG/217 NO

Roh 199693 Korean 48/103 NO

Persson 199694 Black Ethiopian 54/114 NO

Roh 199695 Korean 9/152 NO

Basci 199696 Turkish 1/89 NO

Marandi 199697 Estonian 144/210 NO

Goldstein 199798 Japanese NG/53 NO

Caucasian NG/105

Chinese NG/118

African American NG/108

Xie 199799 Chinese 116/245 YES No gender difference 11.2% vs. 10.9% F to M

Xiao 1997100 Chinese Han 53/101 NO

Ruasi 1997101 Portugese NG/153 NO

NG: Number of women in study not given.
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Biologic/Molecular Basis of Pharmacological Factors

Membrane Transporters. Besides differences 

in drug-metabolizing enzymes, other gender-specific

processes may contribute to differences in absorption,

distribution, and excretion of drugs. These include 

the many membrane transporters, for which therapeutic agents may be substrates, such as the drug 

efflux pumps p-glycoprotein and multidrug resistance

protein (MRP). These transporters pump substrates 

out of the cell, and the overexpression of MRP has

been shown to be linked with resistance to anticancer therapies. The metabolite of the female hormone

estradiol, estradiol-17-beta-glucuronide, is pumped

into the bile by MRP and is also pumped out of 

tumor cells that express MRP.28,29 In addition, female

mice express a higher basal mdr2 p-glycoprotein than

do male mice and thus are able to secrete phospholipids with greater activity.30 Although gender differences in the expressions of the efflux pumps could

contribute to differences in drug pharmacokinetics 

and response, little work has been done in this area.

Ion Channels. In recent years, sex hormones 

have been shown to have effects on tissues other 

than those involved in reproduction. The heart has 

sex hormone receptors, and exposure to these hormones can alter the expression of ion channels 

responsible for the electrical activity of the heart. 

These relationships may help us understand clinical

observations such as the relationship between the 

menstrual cycle and the occurrence of cardiac arrhythmias. Importantly, it may also explain gender differences in cardiac response to drugs. A large number 

of diverse drugs such as antiarrhythmic drugs, terfenadine, astemizole, cisapride, halofantrine, and 

erythromycin have the potential to induce a possibly

lethal cardiac arrhythmia, torsades de pointes. The

mechanism of this not uncommon adverse drug 

reaction is blockage of potassium channels. One

remarkable feature of this adverse event is that 

the risk of developing this type of arrhythmia is 

far greater in women than in men who take these

drugs.4-8 Most likely, this is because potassium 

channel expression and sensitivity to drugs are 

regulated by sex hormones.7 Further research 

in this area is urgently needed.

Increased sensitivity of cardiac sodium channels 

to bupivacaine has been demonstrated after treatment with progesterone.8 Such sensitivity is the 

most likely explanation for reported deaths among

pregnant women given this drug for local anesthesia

during delivery.

In an example of gender differences in receptors, the density of 5-HT2 receptors was found 

to be significantly up-regulated in platelets from

depressed women.31 Therefore, a measure of the 

5-HT2 density may, in the future, be used as a 

marker for depression in women, although not 

in men. However, further research is needed to 

verify this finding. When monitoring for changes 

in physiological levels of prolactin as a function 

of drug therapy, both buspirone and dl-fenfluramine

were associated with greater prolactin responses in

women than in men.32,33 Buspirone and dl-fenfluramine may cause greater changes in normal physiological functions in women than in men. 

Modulators: Sex Hormones. The sex hormones are obviously expressed differently between 

the genders. Exogenously administered steroidal 

hormones, such as oral contraceptives, have been

shown to have effects on drug metabolism.24 Rat 

data have shown that ethenyl steroids bind irreversibly to rat hepatic cytochrome P450, thereby blocking this pathway of metabolic activity.34 In vitro 

evidence suggests that progesterone affects CYP3A4 

by either inhibition or activation.35 Such impairment 

of metabolic capability has significant implications 

for drug-drug interactions when another drug is 

also metabolized by the same P450 enzyme. Whether

endogenous sex hormones are responsible for genderrelated differences in drug response is unknown, but

existing evidence is intriguing. There is evidence, for

instance, that changes in hormonal levels during 

the menstrual cycle may influence the disposition 
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of drugs. For example, among debrisoquine (a marker

for CYP2D6) extensive metabolizers, the debrisoquine

metabolic ratio (MR) was significantly lower in the

luteal phase of the menstrual cycle than in the ovulatory phase or pre-ovulation.36 The metabolism of 

alfentanil and prednisolone, both metabolized by

CYP3A4, are decreased after menopause during 

a time when estrogen and progesterone are greatly

reduced.37,38

Pregnancy and its dramatic effect on sex 

hormones are known to alter drug metabolism. 

An example is the increased elimination of antiepileptic drugs in pregnant women.24 Interestingly,

women who have never given birth were reported 

to have decreased CYP1A2 levels, but those who 

had given birth had the same level of CYP1A2 as

men.39 We are currently unable to predict whether

these changes are generalizable. Until this is studied

systematically, variability in drug response will continue to be a problem in therapeutic dosing. 

Chronopharmacology. Chronopharmacology is the study of the time-dependent dosing 

of pharmacologic agents. Chronopharmacology is

dependent upon inherited factors such as genderrelated differences and genetic variations,40,41

age-related differences,42,43 inter-individual differences in chronoeffectiveness of drugs related 

to diseases such as cancer,44,45 as well as drugdependent alteration due to biological rhythms.

Chronopharmacology also takes into consideration

specified chronobiotics, agents that can influence 

biologic rhythms.

The area of chronopharmacology is relatively 

new, with the establishment of a journal in that 

area in the 1980s. Therefore, chronopharmacology

must take into consideration basic principles of 

medicine and individual patient characteristics. 

Minimal work has been done to examine the 

chronopharmacologic differences or similarities

between women and men.

A chronopharmacokinetic gender-related difference in men and women was demonstrated for the

cephalosporin antibiotic, cefodizine. When this 

drug was administered at four separate times over 

a 24-hour period, the AUCs for women were significantly higher (p<0.001) than those for men. 

The largest AUC occurred at midnight for both 

women and men, and the smallest occurred at 

6:00 p.m.46 Even when chronopharmacokinetic 

effects are observed, other factors may need to 

be considered. For example, in the case of indomethacin, a nonsteroidal anti-inflammatory drug,

chronopharmacokinetic variation has been noted 

in young, healthy subjects and in patients with 

arthritis,42 but not in elderly patients.43

Summary Statement

Importance of Combining Pharmacokinetic 

and Pharmacodynamic Data: Consideration 

of the Interactive Nature of Factors Yielding 

Pharmacological Effects. Although it has become

apparent that there are many gender differences 

in the PK of drugs, the existence or magnitude of 

PD differences cannot always be predicted accurately. This phenomenon is well illustrated in the 

case of the drug propranolol. In the NIH-sponsored

“Beta Blocker Heart Attack Trial,” women seemed 

to have higher plasma concentrations of propranolol than men given equivalent dosages. A natural

response to this information would have been to 

recommend that women be given lower dosages 

of propranolol to correct for their lower clearance 

of the drug. However, Flockhart et al. compared 

the actual degree of beta adrenoceptor blockade 

with propranolol in men and women using an 

isoproterenol challenge infusion and found that 

women had a lower sensitivity to propranolol 

that compensated for their higher plasma concentrations.9 This difference negated the need 

for lower doses, which could have reduced the 

overall efficacy of the drug. Examples such as 

these clearly demonstrate the need to examine 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

PD research in conjunction with PK research in 

order to avoid erroneous conclusions. In addition,

emerging information on other components of 

pharmacological effects should be considered 

in terms of their interactive effects. Figure 2 

provides a new model for considering these 

interactive effects on overall drug safety/toxicity 

and efficacy. 

Preclinical Studies

In keeping with newer approaches to the study 

of pharmacological effects, there is an urgent need 

to develop reliable preclinical (animal and in vitro)

models that will provide information about mechanisms of action of drugs, pharmacokinetics and 

pharmacodynamics, and aid in assessing the role 

of hormones in drug metabolism. More detailed 

preclinical information is also needed to guide 

the planning and implementation of clinical development programs and to improve the efficiency 

of human testing.

Drug Use in Pregnancy

Pregnant women, like all other groups of 

individuals, may benefit from pharmacological 

agents. However, concern for potential fetal harm

caused by drugs taken during pregnancy has 

resulted in exclusion of pregnant women from 

clinical research. This exclusion was also extended 

to women of childbearing potential to prevent 

fetal exposure to unknown effects of a new drug. 

In 1993, FDA issued a guideline that removed 

previous policies that had recommended that 

women of childbearing potential be excluded 

from phase I and II studies of non-life-threatening 

diseases.47 Protocols for drug testing have included 

criteria to minimize the risk of pregnancy in women 

of childbearing potential enrolled in clinical trials 

and taking the experimental agent. Thus, the number of pregnancies where there is exposure to experimental agents is limited. To further compound this

problem, no systematic program exists to monitor 

new drugs for untoward effects on pregnant women

once they are approved despite the widespread use 

of pharmaceutical agents by pregnant women.

Although there may be unexpected adverse consequences when pregnant women take therapeutic 

agents necessary for treatment of a medical problem, the precise etiology of an adverse event is 

often difficult to determine. Background rates of 

3 to 4 percent fetal anomalies, and even higher 

rates of spontaneous and therapeutic abortions, 

confound the clinical picture and may mask a 

drug-related outcome.

In addition to the lack of information on safety 

of therapeutics with regard to fetal outcome, data 

are not available to address safety or dosing considerations for the pregnant woman herself. The 

physiology of pregnancy may provide an environment in which some toxic effects (such as those 

involving hormone-sensitive organs) of particular 

drugs may be more likely to be manifest. Also, 

changes in renal and hepatic function, plasma 

protein binding, and volume of distribution may 

FIGURE 2. Interrelationship of Pharmacological Parameters

PHARMACOLOGIC AGENTS

PG,CP PK MOD

PD BIO/MOL

EFFICACY, SAFETY/TOXICITY

Legend:

PK = pharmacokinetics

PD = pharmacodynamics

PG = pharmacogenetics

CP = chromopharmacology

MOD = modulators of pharmacologic effects

BIO/MOL = biologic/molecular basis of pharmacologic effects
157

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substantially alter the pharmacokinetics of drugs 

in pregnancy so that some drugs may need to be 

dosed very differently in pregnant women and 

nonpregnant women.

Pregnant women have great potential for exposure to medications,48,49 for pre-existing medical 

conditions (such as epilepsy), for conditions occurring during pregnancy (such as hypertension), and 

also through inadvertent exposure before becoming

pregnant or during early-phase pregnancy (before a

woman is aware she is pregnant; in the United States,

50 percent of pregnancies are unplanned).50 Because

most medications have little or no information on 

use during pregnancy or on the risk for the developing human fetus, scientifically valid and rigorous 

preclinical methods for evaluating potential risks 

in pregnant women must be developed. Current 

methods for collecting information on pregnancy 

exposure to drugs are limited. Some pharmaceutical

companies may have a registry to receive reports 

on birth outcomes from women who have taken 

a particular drug while pregnant. However, the 

value of these registries is limited: these registries 

are not widely known, reporting is voluntary, the 

numbers of reports may be small, followup may 

be incomplete, and other factors related to pregnancy outcome may not be well described. 

The FDA may receive an individual report 

when a baby is born with a major malformation 

and the mother remembers having taken a drug 

during her pregnancy. If the birth defect is very 

rare, cluster reports may be helpful. However, this

technique is “numerator” oriented and is unable to

determine the frequency of adverse event occurrence

within the exposed population. This approach can be

used for generating hypotheses, but not for providing

definitive information. Additional studies are usually

needed to determine the nature and strength of any

association between an adverse event and exposure 

to a drug. The problem of establishing whether a 

true association exists is compounded by the bias 

introduced in any retrospective study. Whenever 

there is an adverse outcome, recall of preceding 

events is greater than after a normal outcome. Such

recall bias can be eliminated in prospective studies.

Attention should be devoted to devising systems 

for prospective monitoring of fetal outcomes and 

of performing longer followup studies monitoring therapeutic exposure of pregnant women. The benefits of conducting clinical trials with AZT in pregnant women was demonstrated in the 1990s. There

have also been limited clinical trials of pharmacological agents in halting preterm labor or treating 

pre-eclampsia.

Another potential problem during pregnancy 

is use of dietary supplements. Even though many 

of these substances are not currently tested for 

safety and efficacy, they are being taken in increasing amounts by women, including pregnant women,

who believe they are safe when in fact their safety 

is not known.

Breast Feeding and Maternal Drug Use.

Although the benefits of breast feeding on newborn and infant health and for the maternal-infant 

relationship are well established, it is important to

understand the potential for drug-related infant 

morbidity, via breast feeding, following maternal 

drug intake. Because pharmacologic agents are 

rarely tested for use in lactating women, there 

are many uncertainties regarding their safety 

for breast-fed infants. Research is also needed 

to ensure the safety of breast-feeding women 

and their nursing infants following drug administration during delivery and puerperium. Potential

risks to such infants are increased following multidose, high-dose, or long-standing therapy, particularly in highly vulnerable premature neonates. 

For example, the limited data regarding the safety 

of agents with CNS activity raise concerns about 

toxicity and abnormal neurological development 

in the breast-feeding infant.51 Similarly, there are 

safety concerns for antithyroid drugs, such as the

thioureylenes, which are known to be secreted 

in breast milk.52
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Factors that facilitate the transfer into milk, 

as well as the PK and PD properties of the drug 

in the mother and infant, must be evaluated. Drug

properties that promote low milk concentrations

include large volume of distribution in the serum, 

high protein binding, low lipid solubility, ionization 

at physiologic pH, and large molecular weight. Following transfer into breast milk, drugs with low

bioavailability and short elimination half-lives in

neonates provide increased safety margins.53

For drugs that may pose a potential concern 

to the newborn, steps can be taken to minimize risk.

These include such interventions as selection of alternative effective drug regimens with safer profiles in

breast feeding, timing of drug dosing to minimize 

accumulation in the breast milk, surveillance for 

newborn or infant symptomatology that may be 

a sign of toxicity, or even the determination of 

drug levels in the infant’s circulation.54

RESEARCH 

RECOMMENDATIONS

Recommendations are grouped into the following

areas: Components of Pharmacologic Effects, Preclinical

Studies, and Drug Use in Pregnancy.

Components of Pharmacologic Effects

Recommendations. Examine the underlying 

mechanisms that contribute to gender differences 

in drug effects and disposition encompassing 

topics including, but not limited to, membrane 

transport pumps, ion channels, chronobiology, 

metabolic enzyme differences, sex hormone receptors, drug interactions between hormonal contraceptives and hormone replacement therapy, and 

drugs affecting chemical compounds such as 

the neurotransmitters.

Research Goals. Carry out basic and applied

research on the following:

1. Pharmacokinetics, Pharmacodynamics, and 

the Importance of Combining PK and PD Data

• Develop decision-analysis tools to help 

determine when, and under what circumstances, PK and PD studies should be performed. Assess gender-related PK and PD 

differences in multiple populations including

women with childbearing potential, pregnant

women, lactating women, perimenopausal

women, menopausal women, and senior

women. The examples cited earlier in this

report clearly demonstrate that genderspecific biology, reflected by such modulators as the sex hormones, can have a 

dramatic influence on the physiological

response to drugs. Further research into 

the mechanism of these differences will be

essential before it will be possible to predict 

in advance, or even identify, gender differences that result in increased drug toxicity 

or lack of responsiveness in either sex. 

Adequate research support will be required

when PD studies are warranted.

• Study the effects of drugs in women across 

the life span in relation to drug absorption, 

distribution, metabolism, and elimination, 

with special focus on postmenopausal women

(with and without hormone replacement 

therapy) and senior women who experience

changes in organ function. With regard to

women of childbearing years, the pharmacology working group strongly supported 

continued emphasis on including these 

women in all phases of clinical trials as 

part of drug development. To maximize 

safety and effectiveness of drugs used by 
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these women, interaction of drugs with 

hormonal contraceptives must be studied 

routinely as should pharmacological agents 

for diseases that are common for this age 

group (e.g., autoimmune disorders, depression, HIV, migraine). Other specific topics 

for research include:

• Conventional hormone therapy vs. SERM

• Long-term effects of lifetime estrogen 

exposure (e.g., cancer)

• Gender differences in response to 

chemotherapy

• PK/PD of specific drugs or drug classes 

such as chemotherapeutic agents (e.g., 

tamoxifen), and potassium channel 

blocking antiarrhythmic drugs

• Examine drug interactions, an area that

includes two components: drug-drug and 

drug-nutrient interactions; women are 

underrepresented in studies for both. 

Drug-nutrient (food, vitamin supplements)

interactions have not been well studied. 

Examination of the broad spectrum of 

possible drug-drug and drug-nutrient 

interactions is warranted both for available

pharmacologic agents and for those currently in clinical trials. 

2. Pharmacogenetics

• Research studies are needed that have 

sufficient statistical power to determine the

nature of the interaction between gender and

genetic polymorphism. CYP 450 isoenzymes,

such as CYP 3A4 and CYP 1A2, which are

responsible for estrogen metabolism, may 

also differentially affect other substrates. 

Isoenzyme 1A2 is thought to influence the 

production of 16a-OH and 4-OH, whereas 

3A4 is predominantly responsible for the 

less active 2-OH estrogen metabolite.55

There may be other examples of drug-metabolizing enzymes currently unknown that 

may be differentially expressed in women 

as a whole or in specific racial groups.

• Drug action and disposition may be altered 

by endogenous and exogenous sex hormones.

Estrogen has been shown to inhibit the metabolism of CYP 1A2 model compounds, but 

its effect on the action and disposition of 

other therapeutic agents is not well studied.

The role of CYP 1A2 and 3A4 in gender 

differences of drug metabolism, as well as 

the interface between these isoenzymes 

and estrogen metabolism, induction, or 

inhibition merits further investigation 

with respect to oral contraceptive failure 

and cancer induction.

• The importance of the cytochrome P450 

isoenzymes has long been established. 

CYP 3A4 is quantitatively the most important isoenzyme, making up at least 60 percent of the total P450 hepatic content 

and is responsible for metabolizing the 

majority of medications.56 P450 metabolism is affected by steroid, dietary, and 

medication inhibition and induction.57

There is evidence that CYP 3A4 activity 

is greater in younger women compared 

with men and postmenopausal women.58

Demonstrated decreased metabolism in 

postmenopausal women59,60 may make 

them more liable to adverse effects of 

certain medications. Careful study of 

this possibility is needed.

• CYP 1A2 is also thought to have genderrelated differences in expression. Higher 

plasma levels of 1A2 drug substrates have 
160

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

been reported in women.61,62 In addition, the activity of this isoenzyme has been

found to be reduced in women receiving 

contraceptive medications and during 

pregnancy.63 The potential inhibition of 

CYP 1A2 by estrogen is demonstrated by

decreased caffeine metabolism in women 

receiving estrogen replacement therapy.64

3. Membrane Transporters

• Multidrug resistance may be caused by overexpression of either p-glycoprotein or the 

multidrug-resistance protein (MRP); such 

resistance is characterized by a decreased 

cellular drug accumulation due to an enhanced drug efflux. There may be genderspecific expression of p-glycoprotein and 

MRP related drug efflux pumps and other

membrane transporters. Such gender-related

differences have important value in the 

clinical setting, where decisions must be 

made regarding selection of drug type and 

dosage (e.g., in cancer chemotherapy).

4. Ion Channels

• Differences in sodium and potassium 

channel sensitivities between men and 

women may explain differential adverse 

effects observed following intake of certain

medications. Further preclinical and 

clinical research is needed to better 

define these differences.

5. Modulators

• Sex Hormones as Possible Causes of 

Receptor Sensitivity. Differences in receptor 

sensitivity need to be studied. For example,

women are known to have a longer QT 

interval, which may differentially predispose them to cardiac arrhythmias. 

In addition, women have been shown 

to have lower sensitivity to the beta-blocker,

propranolol, which would not have been 

predicted by PK studies alone; therefore, 

this lower sensitivity is a PD issue.

6. Chronopharmacology

• When examining treatment of diseases 

specific to women, the gender differences 

related to biologic rhythms and their 

application to efficacy of drugs needs 

to be studied. The chronopharmacology 

of disease needs to be studied because 

biologic rhythms may change during 

the disease process and affect the dosing

requirements for a specific drug.

Preclinical Studies

Recommendation. Focus special attention 

on the continued development of animal and other 

models to predict with some accuracy the reproductive and developmental effects of drugs in humans.

With these models in hand, progress may be made 

in understanding safety and efficacy profiles of drugs

and predicting PK and PD with greater accuracy.

Research Goals

1. Evaluate therapeutic efficacy and potential 

side effects through whole animal studies. 

Thus, the effects of estrogens on the cardiovascular system must include information 

on the heart itself as well as the peripheral 

vasculature. 

2. Place receptor and cell-signaling research 

in the context of the whole organism, including physiological and therapeutic considerations in animal research.

Drug Use in Pregnancy

Recommendation. Develop improved methods 

for collecting and analyzing data on the use of pharmacologic agents in pregnancy with respect to safety

and efficacy for the mother and safety for the infant. 
161

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Research Goals

1. Women have a great potential for exposure to

medications not only for conditions occurring 

during pregnancy but also inadvertent exposure prior to knowledge of the pregnancy. 

Since most medications have little or no information on risk for the developing human fetus, 

we must begin to develop scientifically valid 

and rigorous methods of evaluating potential 

risks in humans including frequency of structural and functional birth defects, and reproductive effects such as rates of spontaneous 

abortion. Some anomalies may not manifest 

themselves until later in neonatal development;

thus it is necessary to conduct followup of 

birth outcomes at different times during early 

child development.

2. Critical research should be performed to determine the best systems to link data from a mother

to her newborn. This should be followed by

implementation of such systems for Medicaid 

data, at HMOs, and at academic centers.

3. For those drugs commonly used by pregnant

women, clinical trials in pregnant women, 

particularly in the second and third trimester,

should be performed to address pharmacokinetics and dosing recommendations. All 

trials of drugs in pregnant women should 

collect maternal safety data for the purpose 

of comparison with the safety profile of the 

drug in nonpregnant women. 

4. Most reported birth anomalies are major 

and visible; research is needed on anomalies 

that are more difficult to detect, such as those 

that are neurodevelopmental or immunologic. 

Because of the large number of pharmacologic

agents that may used and the potential for 

adverse effects, this could be a very large 

project. Thus, it is important to establish 

priorities based on the therapeutics taken 

most often by women. For example, what 

effect will antidepressants, especially the 

selective serotonin reuptake inhibitors taken 

by pregnant women, have on the cognitive 

function and development of the child? 

Because currently used classic animal teratology models do not examine immunologic 

markers, research, both animal and human, 

is needed to determine appropriate endpoints 

for assessment of immunologic function.

5. Research is needed on the effects of maternal 

medications on the breast-feeding infant. 

Drug concentration measurements in breast 

milk should be considered for inclusion in 

studies of the PK and PD of new drugs. Based 

on an understanding of mechanisms and 

principles of drug excretion into milk, 

methods should be developed to predict 

infant exposure levels.

Summary of Recommendations

Recommendations for Research

1. Examine underlying mechanisms that contribute to gender differences in drug action and 

disposition. Define the pharmacokinetics, 

pharmacogenetics, chronobiology, modulators, 

biologic/molecular factors, and pharmacodynamics of pharmacologic agents across the life

span (prenatal, infants, children, adolescents,

women of childbearing potential, pregnant

women, lactating women, perimenopausal 

women, postmenopausal women, seniors) 

taking into consideration various racial and 

ethnic groups. Specifically, assess:

• CYP 450s and other drug-metabolizing

enzymes

• p-glycoprotein and MRP-related drug efflux 

pumps and other membrane transporters
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

• Effects of endogenous and exogenous 

sex hormones

• Differences in receptor sensitivity

In addition, examine drug-drug interactions 

and drug-nutrient effects.

2. Perform preclinical research in the development

and validation of in vitro and whole animal 

models to test and predict gender specific 

pharmacologic differences:

• Animal models (e.g., rabbit) to test cardiac 

QT interval differences

• Gender-based whole animal studies of 

pharmacological effects

• Therapeutic agents in pregnancy in prediction of teratologic effects for pharmacological

agents apt to be used during pregnancy.

3. Incorporate research on potential adverse effects

on the pregnant woman, the fetus, and the 

newborn in evaluating PK and PD of new 

drugs. Develop methods of assessing subtle 

effects, such as possible neurodevelopmental 

and immunologic impairment in the child. 

4. Include pregnant women in clinical trials.

Recommendations for Promoting Implementation. Interagency and public-private collaboration 

is required in order to carry out the full range of

research recommended for studying pharmacologic

issues in women, including pregnant women. It is

essential that NIH prioritize studies needed to fill 

the serious data gaps described in this report. NIH

should increase funding allocation for research on 

this topic and encourage interdisciplinary collaboration across all health professions and the basic 

sciences, and development of longitudinal studies 

to cover both basic and translational research. 

Finally, attention to studying mechanisms of 

pharmacologic effects should become an integral 

component of the review process across institutes 

and offices whenever a pharmacologic agent is 

part of a study protocol for prevention or treatment of a disease or condition.

Thanks are due to all working group members 

and especially to Gail Anderson, Marietta Anthony, 

Marianne Rollings, Rosalie Sagraves, Ana Szarfman, 

Terry Toiga, Diane Thompson, Catherine White, 

Ray Woosley, Sheila Weiss, and Cheryl Zimmerman.

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REPRODUCTIVE HEALTH

BACKGROUND

Three issues dominated the discussions 

of the Working Group on Reproductive

Health: (1) progress of reproductive health 

in women’s health research, (2) gaps in knowledge

about reproductive health in women, and (3) the 

current status of women’s health based on updated

information from the past three regional meetings 

in Philadelphia, Santa Fe, and New Orleans.

Historically, “women’s health research” was 

generally limited to the study of obstetrics and 

gynecology. In the late 1970s, however, societal 

shifts, notably feminist concerns about women’s 

interactions with the medical system, resulted 

in a broader national research agenda that encompassed a more comprehensive definition of women’s

health. This drew attention to the lack of research 

on major issues such as cardiovascular disease and 

cancer in women, and the problem of ineffective 

or inappropriate treatment of diseases and conditions in women.

From the late 1980s through the early 1990s, 

the government began to increase funding for 

women’s health research. The Hunt Valley report,

Report of the National Institutes of Health: Opportunities for Research on Women’s Health, 1991,

reflected this new interest. The report took two

approaches to women’s health: (1) a developmental

perspective, looking at women’s health throughout 

the life span, and (2) a basic science perspective, 

looking at women’s health in terms of the state 

of current biological knowledge. These two perspectives still permeate discussions on research 

in women’s health.

The Hunt Valley report posed a series of 

questions intended to guide the women’s health

research agenda. The questions about female reproductive health encompassed basic biology and 

clinical practice. In addition, the report emphasized the need for interdisciplinary work to study 

the effect of social context on women’s health.1

The framework outlined in the 1991 Hunt 

Valley report and in the 1996 Philadelphia report 

governed the current working group’s discussions. 

This framework delineated content areas (e.g., reproductive health, reproductive disorders, special populations) and research strategies (e.g., basic biology, 

clinical research, and social and behavioral approaches)

within the context of research progress, gaps in knowledge, and development of research recommendations.

In particular, emphasis on priorities appropriate to 

NIH biomedical and biobehavioral research were 

addressed. In this context, this report is an updated

compilation of research recommendations and other

agenda issues for NIH’s Office of Research on 

Women’s Health (ORWH).

Cochairs

Florence P. Haseltine, M.D., Ph.D.

National Institute of Child Health and Human Development

National Institutes of Health 

Gloria Sarto, M.D., Ph.D.

University of New Mexico School of Medicine

Wulf A. Utian, M.D., Ph.D.

McDonald Hospital for Women

Case Western Reserve University

Donna L. Vogel, M.D., Ph.D.

National Institute of Child Health and Human Development

National Institutes of Health 

Rapporteurs: Cheryl Campbell and Rafaela-Socorro Roncal

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SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

Pregnancy

Progress has occurred in knowledge relating 

to the biology and management of pregnancy. 

Advances have been made in research on infectious

diseases of pregnancy and preterm labor and on 

other pathophysiologic aspects of abnormal pregnancy. Research suggests that pregnancy can be 

viewed as a screen for detecting diseases or disorders

that may develop later in life. Knowledge is emerging on the effects of somatic disease on pregnancy.

Advances such as genetic testing and other diagnostic tests have provided information on prevention of malformations. An active area is the relationship of implantation (normal vs. abnormal) 

and fetal development.

Recent research has identified external factors 

with potential effects on pregnancy. These include 

environmental factors, diet and nutrition, exercise, 

smoking, and violence. Other external factors 

include the effects of hormones and medications

(including over-the-counter drugs). Diagnostic 

systems are under development that are better 

focused than more traditional diagnostic systems 

and that address the needs of specific populations.

Contraception

Some progress has been made in the knowledge 

of contraceptive use behavior and in generating new

contraceptive technologies. An increased awareness 

has made the long-term effects of contraceptive use 

an important issue, with more research still needed.

Availability of Norplant (levonorgestrel subdermal

implants), Depo-Provera (medroxy-progesterone 

acetate injection), and the female condom are 

promising advances for pregnancy prevention.

There have also been advances in microbicides 

and spermicides and in their use among women. 

This has led to progress in understanding the need 

for women to have more options for the prevention 

of STDs. Recognition of the need for development 

of new contraceptive technologies has important 

implications, especially in specific populations. 

These groups need to be provided with several 

options for different circumstances.

Infertility

An important advance in the area of infertility 

is greater awareness that infertility is a “couple problem” rather than a female problem, and recognition

that male infertility is also a women’s health problem.

Advances were realized in genetic causes of male 

infertility with the potential for heritable infertility.

Advances occurred in the area of ovulation induction

based on developing knowledge of ovarian physiology.

A better selection of treatments for infertility 

has emerged from scientific data. Trial and error 

treatment is obsolete. The best fertility treatment 

would be individualized, based on the couple’s 

characteristics. Pressure for progress in this area 

is being exerted at two points. First, managed care 

and monetary constraints tend to limit choices to 

the most cost-effective treatments. Second, choosing

effective therapy quickly is imperative for couples 

who have delayed childbearing and who face a 

natural decline in fecundity with time.

Progress has been recognized in ectopic gestation, but more knowledge is needed about its etiology,

risk factors, and the effects of therapies on fertility in

the future. New treatments, such as methotrexate, are

improving the medical management of ectopic pregnancy and reducing the need for surgical intervention. 

Reproductive Tract Diseases and Disorders

Progress has been made in promoting greater

awareness of reproductive tract diseases and disorders 

and their prevalence and morbidity. These diseases 

and disorders include myoma, abnormal uterine 

bleeding, premenstrual syndrome, endometriosis,
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VOLUME 2

pelvic pain, and pelvic floor relaxation. New information is emerging on abnormal biology in these 

conditions and in medical and conservative surgical

therapies. Recently identified steroid receptor subtypes may hold clues to development of diseases 

and approaches for treatment. Information is still 

needed, however, regarding the prevalence, etiology

(including potential environmental factors), and 

pathophysiology of these diseases and how they

become symptomatic.

GAPS IN KNOWLEDGE

General Considerations

Two major themes encompass all the recommendations on reproductive health issues. First is 

the need for education. Educating the public and

health professionals will optimize the choices of 

management in reproductive health and diseases.

Health care providers need to be fully, yet critically,

informed about advances in their fields including 

risk factors, diagnostic tests, treatment options, 

and followup strategies, to best advise consumers 

about their care. Consumers need the information 

to understand the pros and cons of options available 

to them, for example in contraception, management 

of pregnancy and delivery, and menopause, as well 

as in diagnosis and treatment of infertility and other

reproductive diseases and disorders.

The second theme focuses on specific populations of women who may have particular health 

care needs or concerns. The interplay of physical, 

biological, psychological, cultural, and socioeconomic factors that affect their access to health 

care services should not be ignored. Neither 

should there be barriers to participation by these

groups in clinical trials. It is important to identify 

the potential differences in each specific population

and how these affect health needs, health outcomes,

and health behaviors across the life span. Specific 

populations include:

• Medically underserved women (such as women 

living in poverty and in rural areas)

• Women of color (having cultural, ethnic, 

and biological differences)

• Women with disabilities

• Adolescents

• Postmenopausal and elderly

• Lesbians

• Women with somatic and/or developmental illnesses. 

Pregnancy

Overall, knowledge is needed on the 

impact of pregnancy and its outcome on women’s

physical and psychological health throughout life. 

A number of gaps exist in all areas of pregnancy. 

Rigorous scientific research is warranted in the 

physiology, management, and sequelae of pregnancy, from preconception to the postpartum 

period. The following conditions should be given 

priority: preterm labor, intrauterine growth retardation (IUGR), preeclampsia, ectopic pregnancy, 

spontaneous abortion, labor and delivery, 

and lactation.

Sound maternal physical and mental wellbeing is essential in bearing a healthy baby; therefore, technology is needed for better monitoring 

the entire pregnancy including screening for fetal

genetic abnormalities and maternal diseases, 

specialized prenatal care followup strategies, 

pregnancy-related medical and surgical interventions (cesarean section, labor pain management), 

and use of alternative treatments. Better data are 

required on the external factors affecting the 

health of the pregnant woman such as: environment, diet, exercise, alcohol intake, smoking, 

violence, and nutritional supplements. 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

More research is needed on the pharmacodynamics and pharmacokinetics of prescription 

and over-the-counter drugs.

Sex and Contraception

Three major concerns are related to sex and 

contraception. First, although knowledge about 

contraceptive use is emerging, more research is 

needed on how to use this knowledge to increase

responsible contraceptive and sexual behavior.

Research is needed on human oocyte physiology

including the use of advanced immunologic technology (e.g., targeting the egg and not the whole 

menstrual cycle). A continuing need exists to 

improve and develop new microbicides, spermicides, barriers, and reversible methods of sterilization. The goal is not only to suit the individual 

couples’ contraceptive needs but also to prevent 

sexually transmitted diseases. Finally, study is 

needed on the long-term effects of existing and 

emerging contraceptives and on their interactions 

with other drugs in relation to women’s health.

Fertility and Infertility

Gaps occur in all areas of knowledge about 

fertility and infertility. Research is needed to develop

measures to prevent infertility and discover costeffective, safer, and less invasive diagnostic and 

therapeutic options through the study of its etiology

and pathogenesis (e.g., increase safety while decreasing the cost of ovulation induction). There is speculation, but few solid data, on the etiology of infertility,

such as the impact of extreme exercise and activity,

smoking, alcohol, eating disorders, obesity, and overthe-counter medications. More should be done on the

behavioral aspects of infertility: effects on the couple,

effects of the diseases that can cause infertility, negative effects of assisted reproductive technology and

other infertility treatments, effects on gamete donors

and surrogate mothers, and social concerns about

reproductive ethics and socioeconomic effects of 

multiple births.

Benign Reproductive Diseases and Disorders

More knowledge is needed about ovarian 

diseases and disorders — polycystic ovarian syndrome, premature ovarian failure, and ovarian 

dysfunction — and reproductive tract diseases 

and disorders — endometriosis, myoma, abnormal 

uterine bleeding, pelvic floor relaxation, premenstrual syndrome, and pelvic pain. The working 

group identified four recurring areas for additional

research, as follows:

1. Application of basic biology leading to 

the evolution of safer, cost-effective, and 

more acceptable treatments (e.g., improve 

current management, develop new diagnostic

strategies and therapeutic techniques). This

includes the use of molecular and genetic 

studies in identifying new disease activity 

markers, and the utility of these markers 

to probe the diseases’ pathogenesis. More 

study is needed on the relationship between 

etiology and epidemiology of the abovementioned diseases and disorders to determine the prevalence and risk factors. This 

information could then be a basis for prevention. The impact of environmental factors

should also be emphasized (e.g., the role of 

smoking in ovarian failure, the role of exogenous estrogen).

2. Long-term biological and psychological 

effects of these diseases and disorders on 

reproductive health, for example, long-term 

effects of current medical and surgical treatments and complementary therapies, such 

as endometrial ablation in abnormal uterine 

bleeding; combination or low-dose hormonal 

treatments in ovarian failure, myoma, and

endometriosis; physical therapy and exercises in pelvic floor relaxation; and behavioral 

and psychological therapy in pelvic pain 

and PMS.
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VOLUME 2

3. Individualization of management. 

4. Changes in the reproductive axis and its 

hormones over time as contributing factors 

to disease pathogenesis. 

Maturation and Aging

Much is to be learned regarding menopause.

Menopause is part of the life of the aging woman. 

Considerable variation exists among individuals 

in manifestation and severity of a variety of symptoms accompanying the transition from pre- to 

postmenopause. These symptoms are poorly 

defined and less understood. Studies should 

be undertaken to fully explore and define the 

physiological stages during this transition and 

its accompanying behavioral and psychological 

effects. The etiology of reduced or defective 

ovarian function may differ in menopause versus 

other ovarian diseases. More research should 

be conducted on the endocrine and metabolic 

changes in normal menopause and accelerated 

ovarian aging. Endogenous and exogenous hormones affect the physiological processes of multiple

target organs in somatic and behavioral health, 

during the peri- to postmenopausal period. More 

studies on HRT are needed to develop novel treatments based on steroid receptor subtypes, steroid

actions, and interactions. Specific areas that need 

to be explored include:

• The safety and efficacy of hormones and 

nonhormonal treatments for menopausal 

symptoms, methods of reducing their side 

effects and of optimizing and individualizing 

regimens for patients.

• The role of estrogen in the initiation and 

growth of hormone-dependent neoplasms 

and other benign diseases and disorders. 

• The role of androgens and dehydroepiandrosterone (DHEA) in quality of life, including 

sexual function of maturing women.

RESEARCH 

RECOMMENDATIONS

The working group agreed that two vital 

themes must be emphasized in conceptualizing 

the recommendations on reproductive health 

issues. These are (1) education of the public 

and health professionals and (2) access of specific

female populations to health care services as well 

as their participation in clinical trials.

Pregnancy

• Conduct more research to better understand 

the whole context of maternal health and 

pregnancy with special attention to preterm 

labor, ectopic pregnancy, intrauterine growth 

retardation (IUGR), preeclampsia, spontaneous

abortion, labor and delivery, and lactation. 

• Study basic physiology, management, and 

sequelae of pregnancy.

• Develop technology for improved monitoring 

of pregnancy — genetic testing, medical and 

surgical interventions, and other alternative 

therapeutic modalities.

• Examine external factors extensively affecting

women’s physical and psychological health —

lifestyle, environment, diet, exercise, alcohol,

smoking, violence, and pharmacology of 

prescription and over-the-counter drugs.

Sex and Contraception

• Focus on research, based on current knowledge 

of contraceptive use, to increase responsible 

contraceptive and sexual behavior (decisionmaking and compliance), especially among 

adolescents and women with gynecological 

infectious diseases. More research is needed 

regarding the role of contraceptives in prevention of STDs.

• Target the biology of the human oocyte to 

develop new contraceptives.
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

• Optimize and develop contraceptive options for

specific circumstances and populations (e.g.,

women with STDs, AIDS/HIV-positive status), 

and study the long-term effects and interactions of existing and emerging contraceptives.

Fertility and Infertility

The working group’s recommendations aim 

to provide more options that suit individual couples’

needs and problems, and pinpoint external factors 

that may contribute to infertility. 

• Learn from biology of the reproductive system 

and focus research on developing and improving

diagnostic and therapeutic measures.

• Understand the etiology and pathophysiology 

to improve fertility and reduce infertility.

• Select the appropriate treatment and management for specific populations.

• Research the behavioral effects of infertility, e.g.,

reducing the negative sequelae of assisted reproductive technology and other infertility treatments,

and their effects on gamete donors and surrogate

mothers, social concerns of reproductive ethics,

and socioeconomic effects of multiple births.

Benign Diseases and Disorders

Benign ovarian diseases and disorders include

polycystic ovarian syndrome, premature ovarian failure, and ovarian dysfunction. Benign reproductive tract

diseases and disorders include endometriosis, myoma,

abnormal uterine bleeding, pelvic floor relaxation, premenstrual syndrome, and pelvic pain. The recommendations reflect the working group’s concerns regarding

the need to learn about the etiology, pathophysiology,

and effects of gynecological diseases and their treatments. The group also emphasized the identification 

of disease markers to estimate prevalence and risk.

• Study the etiology and pathophysiology of 

each of the above diseases or disorders leading to the evolution of safer and more 

acceptable treatments.

• Examine the long-term effects of these 

gynecological diseases and disorders and 

their treatments.

• Discover genetic and molecular factors in 

disease development and identify noninvasive

markers of disease activity.

• Research nonsurgical management of the 

above diseases and disorders.

Maturation and Aging

The working group decided to include this 

topic under reproductive health issues. There 

have been major surprises in how the reproductive system changes normally with time; therefore, 

the working group suggested the need for rigorous 

scientific studies.

• Study consequences of maturational changes 

of the hormonal axes and their effect on fertility,

menopause, and hormone-dependent diseases 

and behavior.

• Study HRT, both existing (estrogen and/or 

progesterone) and potential (androgens, DHEA,

etc.) — its role in novel treatments based on hormone actions and interaction, including receptor

subtypes; safety and efficacy of therapy; detection

and reduction of adverse effects; effects on initiation, growth, or reactivation of hormone-dependent pathologies; and impact on the quality of 

life over time.

The group wished to remind readers that all 

of these recommendations are meant to be viewed 

from the perspective of the general considerations

introduced earlier: (1) the need for public and professional education and (2) the need for attention 

to the individualized needs of specific populations. 

Reference

1 Kirschstein RL. Introduction. Report of the National 

Institutes of Health: Opportunities for Research on 

Women’s Health. Bethesda, Md: National Institutes 

of Health, 1992.
UROLOGIC AND 

KIDNEY CONDITIONS

BACKGROUND

Diseases of the kidney and urinary system 

have a major impact on women’s health.

Permanent kidney failure, called end-stage

renal disease, affects more than 120,000 women in the

United States alone.1 Treatment with dialysis or transplantation, although necessary to sustain life, does not

restore normal, or even near-normal, life expectancy.

The average death rate for end-stage renal disease

patients is approximately 25 deaths per 100 patient

years. Death rates are, of course, very age dependent,

and the average dialysis age of a new dialysis patient 

is close to 60, but even a 50-year-old who develops

end-stage renal disease has only about a 20 percent

chance of being alive 10 years later.1 Thus, at all 

ages, and for both genders, kidney failure results 

in a markedly shortened life expectancy.

Kidney disease is increasing in incidence in 

the United States, where the number of new patients

requiring either dialysis or transplantation approximately doubled between 1985 and 1995.1 While the

increase in incidence has affected women and men

alike, the frequency with which specific diseases 

cause renal failure differs between the two genders.

Particularly important for women is an increase 

in the incidence of Type II diabetes mellitus. Also

important for women’s renal health is the impact of

pregnancy-related kidney disorders. Other forms of

renal disease that are more frequent in women than

men are analgesic nephropathy and the nephritis 

associated with systemic lupus erythematosus. 

Women’s urological disorders are very common,

afflicting virtually all women at some point in their

lives. While less frequently life-threatening than renal

failure, these conditions often have a major impact on

the quality of life. They are often chronic, frequently

misdiagnosed, and inappropriately or inadequately

treated. These conditions can result in social embarrassment and isolation of the afflicted individual. The

chronicity of these disorders may result in excessive

self-treatment to mask symptoms but not cure the

underlying disorder. The pathogenesis of many of these

disorders remains poorly understood, and current 

preventive and therapeutic strategies are inadequate. 

Renal and urological issues were addressed for 

the first time at the conference “Beyond Hunt Valley:

Research for Women’s Health in the 21st Century,” held

in Bethesda, Maryland, in November 1997. The Working Group on Kidney and Urologic Conditions developed an agenda identifying specific diseases of high

priority for their impact on women’s health. For each 

of these conditions, working group participants summarized ongoing research and research advances and

gaps in knowledge and developed a set of research 

recommendations. The working group identified five

aspects of renal health that impact heavily on women

and need research emphasis: (1) end-stage renal 

disease, (2) kidney disease of diabetes mellitus, 

Cochairs

Deborah Erickson, M.D.

Hershey Medical School

Leroy M. Nyberg, M.D., Ph.D.

National Institute of Diabetes and Digestive 

and Kidney Diseases

National Institutes of Health 

Ebrahim E. Versi, M.D., Ph.D.

Brigham and Women’s Hospital

Rapporteur: Verna Hillsamer, M.S.

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VOLUME 2

* Special appreciation is extended to Josephine Briggs, M.D., Director, Division of Kidney, Urologic, and Hematologic Diseases, NIDDK, for her

invaluable contributions to the development of this report.
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

particularly Type II diabetes, (3) analgesic nephropathy, 

(4) nephritis due to systemic lupus erythematosus, 

and (5) renal complications during pregnancy. The

working group also identified four clinical areas in

urology that are particularly deserving of research

emphasis: (1) urinary incontinence, (2) pelvic floor 

disorders, (3) urinary tract infections, and (4) interstitial cystitis and related disorders of bladder function.

End-stage Renal Disease

When the filtering units of the kidney, the

glomeruli, are damaged, the remaining units must 

act to compensate for the loss of the damaged tissue.

With progressive disease, this compensation eventually fails, and the kidney filters less and less. When

chronic kidney disease results in a reduction in 

kidney filtration rate to 10 percent or less of normal capacity, a person is considered to have renal 

failure. Irreversible renal failure is called end-stage

renal disease. Individuals with end-stage renal 

disease require regular dialysis or a kidney transplant to survive. Renal failure is largely gender-blind,

affecting women and men almost equally. Approximately 250,000 people in the United States, approximately 48 percent women, are currently receiving 

renal replacement therapy, with about 70,000 new 

patients a year.1

Therapy for End-stage Renal Disease.

Survival with end-stage renal disease requires some

form of renal replacement therapy. The commonest

therapy is some form of dialysis, either hemodialysis, 

a procedure that cleans and filters the blood through

an extra-corporeal filter, or peritoneal dialysis, which

uses the lining of the abdomen as the filtering membrane. In the United States, of the more than 120,000

women with end-stage renal disease, 64 percent are

treated with hemodialysis and 11 percent are treated

with peritoneal dialysis.1 Cardiovascular disease, 

both heart disease and stroke, accounts for the greatest proportion of deaths on dialysis.1 Despite the 

large impact of vascular disease on the mortality of 

this population, the risk factors for cardiovascular 

disease are poorly defined, and there are currently 

no randomized clinical trials that address potential 

strategies for reducing this risk.

The other form of therapy for end-stage renal 

disease is kidney transplantation. Kidney transplantation rates are severely limited by the number of 

available organs, and waiting times to receive kidney

transplants often exceed 2 years, almost tripling in

length over the last 10 years.1 Although life expectancy of transplant recipients is not fully restored 

to normal, it is substantially better than with other

forms of renal replacement therapy. Transplant recipients need continued immunosuppression, but they

have a life quality that is substantially closer to normal

than dialysis patients. Women and members of certain

racial minority groups seem less likely to receive a 

kidney transplant than are white men and are more

likely to serve as donors for living-related transplantation.2,3 The problems that may limit access of both

women and racial minority groups to transplantation

need continued analysis.

Pregnancy in Dialysis Patients and After Renal

Transplantation. Dialysis patients have reduced fertility, and pregnancies are unusual. The estimated success

rate of carrying to gestation a viable child vary from 

30 to 50 percent, but these values may be skewed by

the greater tendency to report successful outcome.4

Women with kidney transplants, however, quite 

commonly have successful pregnancies,5,6 but they 

are considered high-risk obstetric patients. Specific 

concerns include an increased risk of hypertension 

and infection as well as deterioration in kidney 

function. Pregnancy is not infrequently associated 

with deterioration in function of the transplanted 

kidney, and careful monitoring of blood pressure 

and renal function throughout gestation is critical. 

Statistics suggest that about 12 percent of pregnancies end in spontaneous abortion, the majority 

within the first trimester. Two to 3 percent of 

pregnancies end in second-trimester abortions 

or stillbirth, a rate somewhat increased over that 

of the general population. Pre-term delivery (prior 

to 37 weeks of gestation) is required in as many 

as a third of births. 
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VOLUME 2

The Kidney Disease of Diabetes Mellitus

Diabetes mellitus is the most common cause of

end-stage renal disease, and currently approximately 

40 percent of new cases are due to diabetes.1 Both 

Type I or insulin-dependent diabetes mellitus and 

Type II or non-insulin dependent diabetes produce

renal failure, but much of the growth in diabetic 

renal disease is due to the increase in numbers of

patients with Type II diabetes. According to NHIS 

data, 58 percent of people with Type II diabetes 

are women.7 Certain minority populations, notably

blacks, Hispanic populations, and American Indians,

are disproportionately afflicted by Type II diabetes. 

The enhanced susceptibility of these minority populations, especially blacks and American Indians, results

in substantial disease burdens for these populations.

The factors that account for the increased susceptibility

of certain populations to both diabetes mellitus and

progressive renal disease are not well understood.

While environmental factors and poorer access to 

optimum health care may play a role, uncharacterized genetic factors appear to play a large role. 

Analgesic Nephropathy

A number of studies suggest that daily ingestion 

of high doses of analgesics over a period of years, 

particularly of mixtures containing at least two such

drugs, may lead to adverse effects on the kidney. 

European studies document a rather high prevalence of radiographic abnormalities of the renal 

pelvis in long time users of analgesics and suggest 

that analgesic nephropathy makes a significant 

contribution to end-stage renal disease, causing 

as much as 5 to 15 percent of new cases of renal 

failure.8 In European populations, most patients 

diagnosed with this disorder are women. In the 

United States, analgesic nephropathy is an infrequent

diagnosis among the end-stage renal disease population, accounting for less than 1 percent of new cases. 

However, use of over-the-counter analgesics, such as

acetaminophen, aspirin, and ibuprofen, is quite high 

in the United States. Studies are needed to determine

the true prevalence of this disorder in the United 

States and to assess the factors accounting for the 

variability in the renal toxicity of these drugs. 

Lupus Nephritis

Kidney disease represents one of the most 

common and serious manifestations of systemic 

lupus erythematosus, an inflammatory connective tissue disease that affects different organ 

systems in varying degrees. The majority of 

patients afflicted with systemic lupus erythematosus are young women, mostly blacks of childbearing age. Women of black and Hispanic origins 

have both a higher incidence of systemic lupus 

erythematosus as well as an increased mortality 

from it. The importance of renal involvement 

as a major cause of both morbidity and mortality 

of lupus is well established.9 Thus, an understanding of the causal mechanisms of lupus 

nephritis and of the best treatment is of significance for women’s health.

Renal Complications in Pregnancy

Normal pregnancy is characterized by dramatic

changes in cardiovascular and kidney function, with 

a marked fall in peripheral resistance and augmentation of renal blood flow and glomerular filtration 

rate. Preeclampsia, or pregnancy-induced hypertension, is a hypertensive disease that occurs only 

in pregnancy, complicating almost 10 percent of 

all pregnancies.

Preeclampsia is associated with disturbance 

in the normal regulatory adjustments of renal and 

cardiovascular function. Preeclampsia occurs more

often among certain groups of women including

women under 20 years of age, minority women 

over the age of 35 years, women with chronic high

blood pressure, women who have had high blood 

pressure in previous pregnancies, women carrying

more than one fetus, and women with diabetes.10

Characteristic signs and symptoms usually occur 

after the 20th week of pregnancy and include high

blood pressure, swelling of the limbs accompanied 

by rapid weight gain, and protein in the urine.
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Less commonly, a severe impairment of renal 

function develops in the immediate peripartum or

postpartum period, a condition termed postpartum

hemolytic-uremic syndrome. This syndrome may

develop in women who have experienced normal 

pregnancies and deliveries. It appears to occur 

independent of infections, malignancy, or renal 

injury and may be the result of an altered hormonal

milieu. The long-term renal prognosis depends on 

the severity of the renal damage.

Incontinence

Incontinence has been clinically categorized 

into three broadly defined groups: stress incontinence (urinary leakage during increased abdominal

pressure as with coughing, laughing, and heavy 

lifting); urge incontinence (inability to suppress 

the urge to urinate); and overflow incontinence

(incomplete emptying of the bladder and subsequent spilling of urine when the bladder reaches

capacity). Urinary incontinence is very common. 

A popular misconception is that incontinence 

affects only older women, but large numbers of 

young and middle-aged women also experience 

this significant problem. Prevalence estimates 

vary widely. Among the population between 

15 and 64 years of age, the prevalence of incontinence in women has been estimated from 10 to 

30 percent and in men from 1.5 to 5 percent. 

For non-institutionalized persons older than 

60 years of age, prevalence estimates range 

from 15 to 35 percent, with women having twice 

the prevalence of men. Rates among patients in 

nursing homes are substantially higher, and urinary

incontinence is one of the commonest reasons for 

need for institutional care for the elderly. Despite 

its prevalence and an estimated cost of more than 

$15 billion annually,14 most individuals do not 

seek medical advice. 

Treatments for Incontinence. Development 

of drugs to affect voiding disorders and treat urinary

incontinence is a subject of active investment by the

pharmaceutical industry, and a number of promising

agents are under development. A number of nonsurgical strategies exist to improve urinary continence.

These include the Kegel exercises that strengthen or 

re-train pelvic floor muscles and urinary sphincter

muscles and have been shown effective in reducing 

or curing stress incontinence. Other investigational

strategies to improve bladder function include electrical stimulation to strengthen muscles in the lower

pelvis and biofeedback methods. In the interventional

arena, a number of innovative approaches have been

developed, including the use of artificial sphincters 

and bulking agents or implants to improve tissue

integrity and function. Doctors usually suggest surgery to alleviate incontinence only after other treatments have been tried. Many surgical options have

reported favorable rates of success, although in 

many of these reports the severity of the incontinence prior to surgery is not reported, and the 

length of followup of the treated patient is 

not very long. 

Pelvic Floor Disorders

Pelvic floor disorders encompass not only 

genital prolapse but also the consequent urinary 

incontinence, defecatory disorders, and sexual dysfunction. Annually in the United States, some 400,000

surgical procedures are estimated to be carried out 

for pelvic organ prolapse, many of these for repeat

surgery.11 Despite the magnitude of this clinical problem, little is known about its etiology and how best 

to treat it. The epidemiology of these disorders is not

well characterized. A strong association with multiple

vaginal deliveries is one well established risk factor, 

but many cases are idiopathic. Overall, whether 

altered obstetric strategies can reduce this complication is not well established. 

Urinary Tract Infections

Urinary tract infections remain a common 

problem affecting a wide spectrum of the population,

especially women. Almost all uncomplicated urinary

tract infections occur in women between the ages 

of 18 and 40. Some infections may occur before

menarche, but the incidence increases significantly 
“Interstitial cystitis (IC) was considered, 

and still is considered by some urologists, as an 

‘hysterical female condition.’ Unfortunately, this 

blatantly incorrect label still haunts IC victims 

with the sufferer taking on average 4.5 years to 

get a correct diagnosis and often having to see an

average of five physicians before IC is diagnosed.

Vicki Ratner, M.D.

Interstitial Cystitis 

Association

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in late adolescence and during the second and third

decades of life. It is estimated that by age 30, half 

of all women will experience at least one urinary 

tract infection and about 20 percent of these 

women will have had one or more recurrences. 

Each year, infections of the urinary tract are 

responsible for more than 6 million doctor visits 

and about $4.5 billion in health care costs.16

Interstitial Cystitis

Interstitial cystitis (IC) is a chronic inflammatory bladder condition that affects approximately

450,000 people in the United States, 90 percent of

whom are women. It is manifested by mild to severe

and unrelenting pain, urgency, and extreme urinary 

frequency — sometimes up to 60 or more times in 

24 hours. Neither a cause nor a uniformly effective

treatment have been demonstrated. The symptoms 

are similar to acute urinary tract infection, but urine

cultures are negative for bacteria, and the symptoms

do not respond to antibiotics. Not surprisingly, interstitial cystitis confines many individuals to their

homes. The pain, frequency of urination, isolation, 

and sleep deprivation often make it difficult for 

an individual with interstitial cystitis to function 

in a work environment outside of the home or 

to maintain a normal family life, leading to 

clinical depression.17

SCIENTIFIC PROGRESS

SINCE ESTABLISHMENT

OF ORWH

Significant progress has been made in many 

areas of women’s renal and urological health since 

the establishment of ORWH in 1990, although substantial gaps in knowledge remain. 

End-stage Renal Disease

Highlights in end-stage renal disease include 

the following:

• Recognition that dialysis dose, nutrition, 

vascular access, and proper treatment of 

anemia are all important considerations that 

affect end-stage renal disease patient morbidity

and mortality.

• Development of new drugs for the prevention 

of organ rejection in transplant patients.

• Improvement in survival rates for kidney 

transplant patients, diminished rates of both 

short-term and long-term graft loss.

• Evidence that angiotensin converting enzyme

inhibitors may slow the course of progressive 

kidney disease in individuals with Type I 

diabetes. The use of these drugs during the 

second and third trimesters of pregnancy 

has been associated with a specific pattern 

of birth defects.

• Demonstration that production of the active

metabolite of vitamin D, (1,25 (OH) 2D3), 

a compound not made by the failing kidney, 

is stimulated by estrogens.
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Kidney Disease of Diabetes Mellitus

In recent years, advances in diabetes research 

have led to better ways to attempt to prevent 

and to manage diabetic nephropathy. Major 

advances include:

• Evidence that intensive management of 

blood glucose reduces and may prevent 

development of micro-vascular complications of diabetes.

• Demonstration that angiotensin convertingenzyme inhibitors prevent or delay kidney 

disease progression and renal failure in 

people with diabetes.

• Development of new forms of insulin and 

advances that facilitate intensive therapy. 

These include human insulin produced 

through genetic engineering, better techniques for blood glucose monitoring, 

and external and implantable insulin 

pumps that deliver appropriate amounts 

of insulin.

Analgesic Nephropathy

Important advances in analgesic nephropathy

include the following:

• Molecular characterization of the probable 

targets for analgesic effects on renal function, 

especially characterization of the distribution 

and regulation of the renal cyclooxygenases.

• Improved characterization of the clinical 

presentation of analgesic nephropathy and 

of the specificity of non-contrast computerized tomographic imaging of the kidney 

for its diagnosis.

Lupus Nephritis

Progress in lupus nephritis has been made 

in the following areas:

• Identification of a genetic loci associated 

with an increased risk of kidney disease 

in murine models of this disease.

• New insights into immune cell activation 

and death, pathways of tissue destruction, 

and modulators of lymphocyte or target cell 

function in experimental models of lupus, 

specifically the role of Fas and the Fas ligand, 

with the surprising demonstration that deficiency

in this pathway accelerates lupus nephritis.

• Demonstration that intermittent pulse 

cyclophosphamide therapy has the highest therapeutic index among currently 

available immunosuppressive drug therapies 

in the treatment of proliferative forms of 

lupus nephritis.

• Initiation of randomized controlled clinical 

trials comparing alternate day prednisone 

alone or in combination with either pulse

cyclophosphamide or low-dose cyclosporin A.

Renal Complications in Pregnancy

Progress areas in hypertensive disorders 

of pregnancy include the following:

• Subcategorization of pregnancy-induced 

hypertension as a heterogeneous entity 

comprised of several different subgroups 

including chronic renal disease, borderline 

chronic hypertension, genetic susceptibility 

to hypertension, and genuine pregnancyinduced hypertension.

• Delineation of the importance of endothelial 

cell dysfunction in preeclampsia.

Urinary Incontinence

Progress highlights in urinary incontinence 

include the following:

• Development of treatment guidelines by the

Agency for Health Care Policy and Research 

and the American Urological Association.
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• Improved design and an increase in the 

availability of adult continence products.

• Increased emphasis in patient training for 

self-management of incontinence.

• Improved coverage in medical texts and journals.

• Knowledge that folate supplementation prior 

to and during pregnancy prevents neural 

tube defects, conditions typically causing 

bladder dysfunction.

Pelvic Floor Disorders

Advances in pelvic floor disorders include 

the following:

• Diagnostic standards for genital prolapse 

were established by the International Continence Society and accepted by the American 

Urogynecologic Society and the Society of 

Gynecologic Surgeons.

• Acceptance and understanding that childbirth is a major etiological cause of pelvic 

floor disorders.

• Acceptance and understanding that preventive

measures need to be defined.

Urinary Tract Infections

Highlights in investigation of urinary tract 

infections include the following:

• Development of molecular genetic techniques 

to characterize uropathogens that colonize 

the urinary tract and track the course of 

individual infections.

• Increased understanding of behavioral 

risk factors.

• Advances in the development of vaccination strategies for prevention of urinary 

tract infections.

Interstitial Cystitis

Progress highlights in interstitial cystitis 

include the following:

• Increased public awareness.

• Development of a scientific research community.

• Availability of new pharmaceutical treatments.

• Increased neurophysiological research.

• Establishment of the Interstitial Cystitis Database.

GAPS IN KNOWLEDGE

To further the progress in prevention, diagnosis,

and management of urologic and kidney conditions,

the working group identified the following gaps in

knowledge of particular relevance to women’s health.

End-stage Renal Disease

Gaps in knowledge about end-stage renal 

disease of particular concern for their impact 

on women’s health include the following:

• Studies are needed to define the best strategies 

for reducing the risk of cardiovascular disease 

mortality in end-stage renal disease patients,

including the potential role of hormone 

replacement therapy.

• Investigation should define the factors that 

result in an altered hormonal milieu and 

sub-normal fertility in uremia and mild-tomoderate chronic renal insufficiency, and 

the effect of dialysis dose on these hormonal factors.

• The issue of whether the preventive management of renal bone disease needs to be 

different in the two genders needs to be 

addressed, with particular attention to 

the role of hormone replacement therapy 

in prevention of renal bone disease.
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• Social and cultural issues affecting referral 

and access to transplantation need continued study.

Kidney Disease of Diabetes Mellitus

Despite progress in diabetes research in recent

years, major deficiencies still exist in many areas. 

A recent NIH-sponsored symposium on diabetes 

identified numerous research challenges and knowledge gaps, the scope of which are too broad for 

this report. The most important highlights, as 

they pertain to this report, are the following:

• Studies are urgently needed to understand the

mechanisms of deterioration of renal function 

in diabetes, including genetic determinants.

• Studies are need to establish the role of 

tight glycemic control in prevention of 

diabetic kidney disease in patients with 

Type II diabetes.

• The role of lowering blood pressure to levels 

below standard targets in slowing or preventing diabetic kidney disease needs study.

Analgesic Nephropathy

Knowledge of analgesic nephropathy needs 

to be improved with particular attention to the 

following areas:

• Safety of long-term use of high doses of 

acetaminophen, alone or in combination, 

needs continued investigation. Of particular 

concern is the possible effect on pre-existing 

renal disease.

• Behavioral studies to assess which factors 

predict heavy analgesic use and long-term 

evaluation of strategies to alter over-use 

of these agents are needed.

• Better diagnostic tools to diagnose and 

monitor analgesic nephropathy are of 

high priority.

Lupus Nephritis

Understanding of lupus nephritis is lacking 

in many areas, as highlighted below:

• Etiology of lupus and nature of the genetic 

determinants that modify the clinical presentation remain unknown.

• Progressive kidney disease results from inflammation amplified by resident renal cells that 

have been activated in an antigen-independent

manner. However, molecular mechanisms of 

cellular activation continue to elude definition.

• There is a lack of knowledge of the role 

of cytokines in the pathophysiology of 

lupus nephritis.

• Studies to examine the reasons for the female 

preponderance among lupus patients should

include examination of the action of estrogens 

in the pathogenesis of the disease, as well as 

the examination of X-linked genetic factors.

Renal Complications in Pregnancy

Gaps in knowledge about renal disorders 

of pregnancy include:

• There are no measures that can consistently 

distinguish pregnancy-induced hypertension 

from hypertension due to underlying renal 

disorders or pre-existing hypertension, hampering research on the etiology of pregnancyinduced hypertension.

• The determinants of and the factors influencing 

the changes in renal function during pregnancy 

are still incompletely understood.

• The frequency with which pregnancy results 

in clinically significant deterioration in renal 

function in women with pre-existing renal 

disease and renal transplants is poorly defined.

This issue is of substantial importance to 

women with these conditions who are 
“. . . the most common cause of postmenopausal women undergoing gynecologic surgery is 

for the treatment of urinary incontinence and/or 

organ prolapse.”

Nicolette S. Horbach, M.D.

American Urogynecologic 

Society

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contemplating pregnancy. Prospective, 

observational studies are urgently needed. 

Urinary Incontinence and Pelvic Floor Disorders

Understanding of urinary incontinence and 

pelvic floor disorders is lacking in many areas, 

as highlighted below:

• The following issues need investigation using 

the tools of basic science:

– developmental biology of the genitourinary

tract and pelvic structures

– nature of the anatomical abnormalities 

of the pelvic floor which underlie prolapse

– normal physiology and pathophysiology 

of the bladder and pelvic floor structures.

• In the area of epidemiology, there is a lack 

of information on:

– natural history of these disorders 

– prevalence and incidence by sociodemographic factors (specifically minority 

and younger populations)

– risk factors including childbirth, exercise, 

diet, obesity, smoking, hormone deprivation.

• Consistent clinical and research definitions 

need to be developed, incorporating both 

subjective and objective measures.

• Awareness of these disorders by physicians, 

particularly primary care physicians, and 

allied health professionals need to increase.

• Studies are needed to define the economic, 

social, and psychological impacts of 

these disorders.

• Investigation evaluating surgical outcome 

and comparing alternative surgical interventions for both genital prolapse and urinary 

incontinence are urgently needed. Studies 

need to examine long-term recurrence rates.

Interstitial Cystitis

In the area of interstitial cystitis, the following

gaps in knowledge were identified:

• Improved description of the epidemiology 

of the disorder is needed.

• Further investigation of potential etiologies 

should occur.

• Studies need to be undertaken to establish 

markers for the diagnosis of the diseases 

and for monitoring the efficacy of treatment.

• High priority should be given to continued 

investigation of therapeutic strategies, both 

for symptom control and potential cure. 

Urinary Tract Infections

Gaps in knowledge regarding urinary tract 

infections include the following:

• Understanding of the molecular epidemiology 

of urinary pathogens is needed.

• More complete characterization of factors, 

such as surface adherence molecules, that 

make a uropathogen pathogenic may lead 

to new therapeutic strategies.
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• Further studies are needed to understand 

mechanisms of transmission.

• Investigation is needed into the mechanisms 

of chronic recurrent infections and the risk 

factors for recurrence.

• Behavioral risk factors especially in women 

over 40 years of age and impact of hormone

replacement therapy in prevention are topics 

needing further study.

Overarching Gaps of Special Concern

The working group also identified general 

gaps in knowledge about urologic and kidney 

conditions that affect a number of conditions. 

These include a lack of understanding of:

• Role of hormonal changes in the genitourinary system, and impact of hormone 

replacement therapy.

• Childbirth effects on the anatomy of the 

pelvis and bladder.

• Female sexual dysfunction and behavior 

as it relates to pelvic floor disorders.

• Prepubertal development and relationship, 

if any, to conditions appearing later in life.

RESEARCH 

RECOMMENDATIONS

The Working Group on Urologic and Kidney 

Conditions made the following recommendations 

for priority areas for future research:

• Attract more basic science researchers from a 

variety of scientific disciplines into these fields 

by workshops that target a variety of disciplines

and by increasing funding for research and 

training programs.

• Establish the effects of chronic analgesic use 

on renal function, and the incidence of analgesic nephropathy in the end-stage renal 

disease population in the United States.

• Initiate prospective observational studies on 

the impact of pregnancy on renal function 

in women with underlying kidney disorders 

and renal transplants. Studies should define 

the effect on both the short- and long-term renal

prognosis, as well as pregnancy outcomes.

• Conduct research to determine the causes of

altered renal hemodynamics during pregnancy.

• Conduct studies to establish the optimum

approach to hormone replacement therapy 

in women with chronic renal insufficiency 

and end-stage renal disease.

• Expand research on the pathogenesis of lupus

nephritis to exploit current insights in inflammatory mechanisms and cytokine pathways.

• Undertake investigation to improve strategies 

for prevention of diabetic nephropathy, particularly that due to Type II diabetes.

• Conduct basic science research on bladder 

and pelvic floor disorders including physiology 

and pathophysiology.

• Develop and validate standard measures for 

assessment (baseline conditions and outcomes) 

for urinary incontinence, interstitial cystitis, 

and pelvic floor disorders.

• Initiate new (and utilize existing) longitudinal epidemiological and interventional studies

using diverse populations on urinary incontinence, pelvic floor disorders, and urinary 

tract infections including the impact of 

childbearing and aging.
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• Initiate valid and controlled clinical trials for 

the treatment and prevention of incontinence,

pelvic floor disorders, urinary tract infections, 

and interstitial cystitis. These clinical studies

should not be relegated to the industrial sector.

References

1 U.S. Renal Data System. Annual Data Report, 1997.

Bethesda, MD: National Institutes of Health, National 

Institute of Diabetes and Digestive and Kidney Diseases,

USRDS, April 1997.

2 Delano BG, Macey L, Friedman EA. Gender and racial 

disparity in peritoneal dialysis patients undergoing renal

transplantation. Am Soc Artificial Org J 1997;43:861-47.

3 Bloembergen WE, Mauger EA, Wolfe RA, Port FK. 

Association of gender and access to renal transplantation. Am J Kidney Dis 1997;30:733-8.

4 Daugirdas JT, Ing TS. Handbook of Dialysis, 2nd ed. 

Boston: Little, Brown, 1988.

5 Allen RD, Chapman JR. A Manual of Renal Transplantation.

London: Edward Arnold, 1994.

6 Davison JM, Lindheimer MD. Pregnancy in women 

with renal allografts. Semin Nephrol 1984;4:240. 

7 Diabetes In America, 2nd ed. Bethesda, MD: National

Institutes of Health, National Institute of Diabetes and

Digestive and Kidney Diseases, 1995.

8 De Broe ME, Elseviers MM. Analgesic nephropathy. 

New Engl J Med 1998; 338(7):446-52.

9 Hayslett JP, Kashgarian M. Lupus nephritis. In: Schrier 

RW and Gottschalk CW, eds., Diseases of the Kidney, 

5th ed. Boston: Little, Brown, 1993.

10 Management of hypertension in pregnancy. ACOG 

Technical Bulletin. Washington, D.C.: American College 

of Obstetricians and Gynecologists, 1994.

11 Jones DC. Pregnancy complicated by chronic renal 

disease. Clin Perinatol 1997; June 24 (2):483-96.

12 Hayslett JP. Postpartum renal failure. New Engl J Med 

1984;312:1556-59.

13 Jungers P, Chauveau D. Pregnancy in renal disease. 

Kidney Int 1997; October 52(4):871-85. 

14 Fantl JA, Newman DK, Colling J, et al. Urinary Incontinence in Adults: Acute and Chronic Management. 

Clinical Practice Guideline, No. 2. 1996 Update, U.S.

Department of Health and Human Services, Public 

Health Service, Agency for Health Care Policy and

Research. AHCPR Publication No. 96-0682. 1996.

15 Ostergard DR, Bent AE, eds. Urogynecology and Urodynamics, 4th ed. Baltimore: Williams & Wilkins, 1996.

16 Zamula E. Help for urinary tract infections. FDA Consumer Special Report: Your Guide to Women’s Health, 3rd

ed. Rockville, MD: Food and Drug Administration, 1997. 

17 Hanno P. Interstitial cystitis and related diseases. In: 

Wash P, ed., Campbell’s Urology, 7th ed.. Philadelphia: 

W.B. Saunders, 1998.

Career Issues for women Scientists

CAREER ISSUES FOR

WOMEN SCIENTISTS

BACKGROUND

When the Office of Research on Women’s

Health (ORWH) was created in September 1990, one part of its threefold mandates was “to develop opportunities and support for

recruitment, retention, re-entry, and advancement of

women in biomedical careers.” To that end, ORWH

convened a series of meetings, with both female and

male participants, to discuss areas of concern and 

recommend solutions that will assist women scientists in the areas of education and career.

Women in Biomedical Careers: Dynamics of Change;

Strategies for the 21st Century met in 1992 and produced a workshop report with recommendations. 

Nine general issues or barriers were identified that 

are common to women biomedical professionals

regardless of race, ethnicity, culture, or scientific 

discipline.1 These are:

• Recruitment

• Role models and mentors

• Career paths

• Re-entry programs

• Family and career conflicts

• Discrimination and harassment

• Research on gender and health

• Gender sensitivity

• Minority women

In November 1997, the Working Group on 

Career Issues for Women Scientists met in Bethesda,

Maryland, where it discussed areas of concern and

progress and developed final recommendations for

ORWH. Its recommendations are new ideas from 

this meeting as well as recommendations from 

the previous meetings. 

PROGRESS SINCE 

ESTABLISHMENT 

OF ORWH

NIH Programs and Initiatives

In 1991, Dr. Bernadine Healy, then-Director 

of NIH, established a task force to look at the 

status of NIH intramural women scientists. The 

task force found several impediments to career 

development and proposed the following solutions. They were: 

Communication. The task force identified a 

perception of communication problems on the part 

of women scientists who feel “out of the loop” with

respect to various issues at NIH because so few of 

them hold senior leadership positions. The task 

force suggested that every institute elect a woman 

scientist advisor to meet regularly with the institute’s scientific director to discuss issues affecting

women scientists. Additionally, the woman scientist

advisor attends all laboratory and branch chief 

meetings. The advisor reports back regularly to 

the women scientists. 

Cochairs

Catherine Didion

Association for Women in Science

Joan Y. Reede, M.D.

Harvard Medical School

Joan P. Schwartz, Ph.D.

National Institute of 

Neurological Disorders and Stroke

National Institutes of Health 

Eleanor G. Shore, M.D., M.P.H.

Harvard Medical School

Rapporteur: Roxanne Smith

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Recruitment and Promotion and TenureTrack Plan. To facilitate recruitment and promotion of women, the task force recommended that 

every NIH search committee include at least one

woman scientist advisor and, where possible, 

one minority advisor. All searches are broadly 

advertised nationwide to minimize the effects 

of the “old-boy network.”

Visibility. To improve visibility of women 

scientists, the task force recommended that a lecture

series be named after the first woman laboratory 

chief at NIH, Margaret Pittman. NIH screens prospective speakers to ensure a proportional representation of women and minorities speaking in 

all NIH lecture series and workshops.

Pay Equity. The Women Scientist Advisory 

Committee identified sizable disparities in pay 

between tenured men and women scientists. The

Department of Health and Human Services agreed 

to a one-time pay correction that resulted in pay

adjustments for 45 out of 200 tenured women, 

four minorities, and one man. NIH also adjusted 

salaries for female and minority postdoctoral fellows in Government positions. For those on “real” 

fellowships, the pay scale is on tight bands with 

only a small range between the minimum and 

maximum pay levels.

Flexible Leave Plan. The Family and Medical

Leave Act gave all federal employees access to 

limited leave for specific family or medical reasons.

NIH extended these privileges to postdoctoral fellows (who are not employees by technical definition) 

for up to 6 weeks of paid leave for maternity. NIH 

also built into its 6-year term tenure track a “stopthe-clock” mechanism that permits up to 1 year 

to attend to family matters. 

Intramural Career Development. NIH’s Office 

of Education sponsored an intramural career development program that teaches fellows about job negotiation, presentations, and professional life issues. The

office also sponsors a predoctoral internship award 

for recent college graduates that enables them to 

spend a year in an NIH laboratory while applying 

to graduate or medical school.

In addition to these task force recommendations, in 1992, ORWH developed a pilot program,

which all the NIH institutes now support, to assist 

scientists who are re-entering biomedical careers. 

The program focuses on men and women who 

withdrew from their careers because of family 

responsibilities such as caring for children or an 

ill family member, but who during their time away

stayed partially involved in their science careers. 

Applicants to the program identify mentors with 

investigator-initiated research grants (RO1s) or 

other NIH grants who will receive a supplement 

to their grants to support re-entering scientists 

for 2 to 3 years of retraining. A 1995 analysis 

of the program found that the scientists were 

still employed in research positions 2 years 

after completion of the program.

Another NIH opportunity is aimed at reaching young women and minority students in the 

precollege years. Data have established that most 

young girls leave the fifth grade liking science 

and considering it as a career. By the time they 

are in high school, however, the same young 

women no longer consider science a career 

option. The NIH Office of Science Education 

(OSE), with funding from ORWH, is undertaking efforts targeting kindergarten to college-level

women to increase their interest in science. 

OSE is working on a series of posters aimed 

at middle-school girls that depict women in 

medical research. OSE also created a web site 

for middle and high school students. The web 

site contains “Research in the News,” which 

provides information on news and breakthroughs 

in science; “Cool Links,” which points users to 

other science education resources; and “People 

Doing Science,” which profiles NIH employees, 

such as a genetic counselor, a speech pathologist, 

or a medical librarian.
“It is our view that it is unconscionable to allow

talented women (and men) to wither on the academic

vine when a modest amount of support could maintain

their academic careers and preserve their capacity to

contribute to the research and teaching that are

absolutely vital to the future of medicine.”

Eleanor G. Shore, M.D., M.P.H.

Harvard Medical School

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Non-federal Programs

Because nursing is a profession that has only

encouraged research careers in recent years (what 

is now the National Institute of Nursing Research 

was only founded in 1986), a number of nursing

schools have created inhouse research centers to 

provide an infrastructure in support of such development. At their best, they make available seed 

grants and research assistants, provide statistical 

consultation and editorial assistance, connect 

faculty with mentors and campus resources, assist 

in budget preparation, and other help. The staging 

of mock grant reviews, patterned after the NIH 

review panels, are used to prepare faculty for the 

rigors of peer review, and thus improve the quality 

of grant applications.

Harvard Medical School developed a program in 1995 that provides 10 fellowships a year 

for junior faculty who want to teach, conduct 

research, compete for grants, publish, or practice 

(if a clinical faculty member) at the same time 

they are assuming increased family or other 

responsibilities. Faculty may apply for a $25,000 

fellowship that will buy protected time for writing 

a grant application, finishing a research project, 

preparing a manuscript, or developing a new curriculum. The fellowship also provides funds for 

additional laboratory assistance. The Office of 

Faculty Affairs at Harvard intends to continue 

these fellowships, with a new competition each 

year, for at least 5 years. In the first year, Harvard

granted fellowships to nine women and one man 

out of 210 applicants.

For women at the associate professor level 

who want to progress into administration, the 

Office of Faculty Affairs at Allegheny University 

of the Health Sciences has developed a program 

called Emerging Leaders in Academic Medicine. 

Participants are in residence for two 1-week 

sessions that include workshops on developing 

leadership skills and mentoring. Women who 

participate must show that their university administration is committed to the program, and the dean 

of the school is required to attend 2 days of the 

last session.

Several organizations have published information on sexual harassment and discrimination. 

The Council of Graduate Medical Education’s 

Fifth Report: Women and Medicine found that 

the greatest obstacle for women in medicine is 

sexism. The Association of American Medical 

Colleges offers a variety of materials on the status 

of women in medicine — from statistics on women 

at all levels to a compendium entitled Building a

Stronger Women’s Program. Janet Bickel’s book, 

Enhancing the Environment for Women in Academic 

Medicine (1996), includes chapters on sexism in 

medicine and on salary-equity programs.

The Department of Surgery at North Shore 

University Hospital in Manhasset, New York, sends 

The Pocket Mentor to all new interns, particularly

women. A good resource for all institutions looking 

for women candidates is the reference manual that 

lists women with their subspecialty of medicine. 

A book by Dr. Deborah Swiss of Harvard addresses

“Mommy-track” issues.
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GAPS IN ADVANCEMENT

OF WOMEN IN 

BIOMEDICAL CAREERS

The working group discussed common 

themes and recommendations from the previous ORWH meetings and raised new issues 

to be addressed.

Data Collection, Monitoring, and Dissemination

Data Collection. As more women scientists

acquire leadership positions, they face issues traditionally handled by men. Collecting data is an option

for use in supporting and ensuring the success of

women leaders. For example, collecting data on

women chairs of basic science departments across 

institutions will facilitate communication among

women leaders to enable networking, brainstorming, and discussion of leadership styles. 

Few databases are available that contain benchmarking or best practices data that could be used 

to improve conditions at an institution. For example,

identifying the best mentoring programs is difficult

because so many are currently available.

Salary Program Monitoring. Some institutions

may pay women faculty less than men. NIH should

mandate that institutions receiving federal funding

make salary information available to ensure equal 

pay for similar training. Some organizations publish

and post their salary information on websites. The

IPEDS Interactive Database at Arizona State University (http://ncda.org/ipeds), for example, contains 

information on faculty salaries, including faculty 

salary sex differences, for hundreds of institutions.

Dissemination. NIH plans to expand the availability of public information. Any existing databases

need to be amalgamated and could, for example, 

contain information on principal investigators. 

Electronic Technology. Women should be 

encouraged and supported in the use of computers 

and the Internet. This technology needs to be 

accessible to all women. 

Marketing and Outreach. The lack of sufficient

marketing and information outreach regarding 

women’s health is a concern. 

Institutional Responsibility, Collaboration, 

and Partnering

Institutional Responsibilities. The working

group identified a number of areas in which institutions should assume more responsibility.

Equal pay for equal work remains a difficulty.

Department chairs in state or other institutions 

work within bureaucracies. The longer a scientist 

(male or female) remains in a particular grade (and

women frequently remain in a grade longer because

they leave temporarily for childbearing or other 

reasons), the less likely he or she will receive a 

pay raise. Chairs or deans have difficulty giving

employees the pay increases they deserve. 

Likewise, sponsoring organizations may have 

trouble identifying an office or a contact person 

to assist women with disabilities at conferences. 

This type of information could help disabled 

people easily specify their needs.

Collaboration and Partnering. Collaboration 

and partnering among organizations are important,

particularly because 50 percent of the biomedical

research budget is in industry and many women 

spend their careers there. ORWH needs to work 

not only with professional scientific organizations 

but also with the American Association of University

Women (AAUW), the Association for Women in Science (AWIS), and the National Science Foundation

(NSF) (which have programs directed at the precollege student), as well as with the major business

research organizations. Collaboration would ensure

that resources are spread out and do not target the

same group. Actions taken in concert and under 

NIH leadership can catalyze outcomes.
“The number of black nurses with earned 

doctorates represents less than 1 percent of all 

professional nurses in the United States.”

Linda Burnes Bolton, Dr.P.H., R.N.

National Black Nurses 

Association, Inc.

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Community partnering depends on links with 

professional associations, academic health centers,

practitioners, and industry. Middle school students

who are at risk because of environmental or social 

circumstances often are creative children with much

potential. NSF or NIH scholars and experts should 

be encouraged to participate in community linking 

by visiting public schools and speaking with elementary, middle school, and high school students about

careers in medicine and the health sciences. Many 

NIH institutes have adopted local Washington, D.C.

schools, and NIH scientists visit the schools throughout the school year to talk with students about 

science and research at NIH.

Education. Generally, teachers are not prepared

for educating and encouraging children in science. 

On the other hand, most graduate schools are reassessing whether they are producing too many Ph.D.s.

Reassessment of graduate education and training 

needs to take place.

Leadership

Leadership requires more emphasis. Much effort 

is devoted to attracting young women to scientific

careers and keeping them there, but as women gain

seniority, few attain leadership positions. Approximately 183 women chair medical school academic

departments.1 Female deans, vice presidents, and

department chairs do not necessarily have peers 

within their own organizations. They need to network for survival in these high-level roles, with 

the help of data collection, as mentioned earlier.

Mentoring

Mentoring is a major need if we are to lessen 

the number of women leaving career paths. But 

mentoring is time-intensive for faculty, reduces time

available for research, and is rarely a criterion for 

promotion. A specific proposal is that success in 

finding, retaining, and placing women and minority

graduate and postdoctoral students should be a 

major criterion for judging, funding, and renewing training grant applications.

There is a need to identify institutions with 

programs that reward mentoring and offer a flexible

schedule. Several medical societies have mentoring 

programs to attract students at precollege levels. 

Linking into such programs to a database would 

benefit women.

Cultural Issues and Social Norms

Women are increasing their numbers in medical school — women constituted 43 percent of new

entrants and 42 percent of total enrollment in U.S.

medical schools.2 The proportion of women in 

medical residency programs was 34 percent in 

1996, and the highest proportion of women residents was in pediatrics.2 However, women are 

leaving because the medical school culture involves

such long work hours and large workloads that 

there is no time for family. Women who stay too 

often give in to the culture.

How we value the contributions of women 

as scientists and how we measure that value are 

of concern. The work of women should not be 

assessed using male-oriented expectations of 

behavior, because women often have different 

working styles due to family constraints. Benchmarks should be developed to evaluate quality 

of work, regardless of the style used to achieve 

that work. Some women have assumed particular 

leadership styles to achieve success, which may 

be counterproductive to the best strengths and 

values of women. There are multiple ways to 
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obtain the same goal, and we need flexibility in 

time, age, and career sequence. Different work 

styles should be encouraged to accommodate 

the needs of all women.

Our current education and health care 

delivery system was haphazardly put together 

to benefit the social class and gender of the people 

who traditionally performed this work. We are 

now trying to fit excluded people into a system 

that was not designed for them. We need to examine our medical education, working conditions

including the lack of sleep for residents, and the 

timeframe for training in terms of the needs of 

women. Premedical training, medical school, and 

residencies make it nearly impossible for women 

to have children during the ideal childbearing 

years. This is particularly true of the field of surgery. Women still face discrimination and harassment, most of which occurs in medical school 

and during residency training. Once women finish

training and go into practice, the prevalence of 

harassment drops substantially. Institutions need 

to make academic medicine a more secure 

environment for women.

Women in the health professions face a particular kind of discrimination. Too often those in 

the traditionally female-dominated professions, 

nursing and social work, are perceived as not needing to do research to expand their knowledge base, 

and they are dissuaded from research training. 

Support for individuals in these professions is 

further limited by the fact that the questions they 

study usually exist on the interface between the 

behavioral and the biomedical sciences (e.g., family

adaptation to a child’s chronic illness), an area of

tremendous clinical importance, but one requiring

complicated scientific methods and an interdisciplinary perspective. Thus, scientists in these areas 

face the added dilemma of feeling not always welcome by the scientific community at the same 

time that they are struggling to study problems 

not subject to the rigorous control as bench 

science, which only reinforces traditional beliefs 

that they may not belong.

RECOMMENDATIONS

Overarching Principles

The following recommendations apply, where

appropriate, to the entire educational and career 

path from grammar school up to and through medical school and the various health science careers. 

The intent is to include all populations of women,

including the disabled, all ethnic and racial groups,

and those with different sexual orientations. ORWH 

will need to collaborate with external agencies, 

associations, academic institutions, and other 

entities to accomplish these complex tasks.

Data Collection, Monitoring, and Dissemination

Data Collection

• Create a comprehensive database on women

scientists by field, a database that should be

widely available to university and industry

search committees for new laboratory chiefs,

division heads, and department chairs.

FIGURE 1. Ethnicity of Female Faculty in

U.S. Medical Schools

Source: American Association of Medical Colleges (AAMC) Faculty Roster System. Bickel J,

Croft K, Johnson D, and Marshall R. Women in U.S. Academic Medicine Statistics 1997,

Washington, D.C.: AAMC, 1997. Used with permission.

Non-White (4,014) Total (22,779)

Asian (2,272) 10%

Black (938) 4.1%

Mexican American (108) .5%

American Indian (30) .1%

Other Hispanic (427) 1.9%

Puerto Rican (239) 1%

Non-White

(4,014)

17.6%

White

(17,299)

75.9%

Unknown

Ethnicity

(1,466)

6.4%
“We have come a long way from where we 

were, and we still have a long way to go, but we 

will get there.”

Carola Eisenberg, M.D. 

Harvard Medical School

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• Catalog and organize a list of existing databases to include emerging leaders, mentors, 

and special populations of women.

• Identify new database needs.

• Collect outcome data to determine the 

effectiveness of specific programs targeted 

at women scientists.

Program Monitoring for Institutional Accountability

• Evaluate effectiveness of principal investigators in supporting academic careers of

women and minority scientists.

• Evaluate effectiveness of institutional 

programs aimed at enhancing careers 

of women and minorities.

• Collect statistics on gender gap issues 

such as salary, tenure, and percentage 

of women at senior levels.

Dissemination

• Develop mechanisms for disseminating 

information and data for those with and 

without Internet access.

• Lend support to institutions whose faculty 

are still unable to gain Internet access.

• Expand the ORWH web site for disseminating research information and other 

data pertaining to women scientists.

• Link ORWH web site to other databases 

and web sites within NIH and in professional

societies, biomedical organizations, academic

institutions, and community groups.

Institutional Responsibility, Collaboration, 

and Partnering

• Encourage each institution to create new 

programs to address inequities in representation and participation of women and 

minorities in science and medicine.

• Include in expectations for NIH-funded 

principal investigators the point that training for investigators should include:

– Requirements for special attention to 

recruiting, training, and advancing all 

underrepresented groups in medicine 

and biomedical sciences

– Requirements for institutional responses 

to harassment and discrimination at all 

ranks, but particularly in training programs.

• Issue a contract from NIH for models of 

institutional self-study and corrective actions 

for any practices that hinder or discourage 

underrepresented groups from full participation 

in research and training in biomedical research.

• Increase participation of underrepresented 

groups at all levels in NIH, e.g., study sections,

advisory groups, conferences. The same point

applies to partnering institutions where appointment to committees, invitations to speak, and 

travel to conferences all add to the academic 

maturation of the faculty member.

Education and Training

• Encourage institutions to increase efforts 

to introduce science into the education 

of children from kindergarten through 

high school. 
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• Encourage NIH to offer competitive funding 

to increase the ability of individual institutions 

to develop quality programs to attract able 

young people into the biomedical sciences.

• Support and expand existing programs 

that encourage the exposure of women 

and minorities to science and medicine 

at the precollege level in order to increase 

the pool of student applicants from underrepresented groups.

• Expand the NIH OE Scholarship Program 

for Minority Undergraduates with more 

vigorous outreach. 

• Establish partnership between NIH and 

academic institutions, industry, or professional

societies to develop programs for enhancing 

careers of women scientists.

Career Enhancement

• Expand the ORWH re-entry program. Providing opportunities for women who have already 

completed their professional training but have

taken time off for family reasons will salvage 

precious talent and encourage women to 

resume careers in science.

• Develop and fund a national fellowship program to support protected time for academic 

activities of women junior faculty at those 

points in their careers when they must teach, 

conduct research, compete for grants, publish, 

and practice (if a clinical faculty member) at 

the same time they are assuming increased 

family or other responsibilities. Such a program would be particularly valuable for 

women in science and medicine, but could 

be made available to men junior faculty if 

they face similar obstacles. (See Harvard 

Medical School’s 50th Anniversary Program 

for Scholars in Medicine as one possible 

model, as described on page 189.) 

• Establish collaborative programs with the 

Department of Education and Department 

of Rehabilitative Services. 

Leadership and Visibility

Leadership Training

• ORWH should support appropriate 

professional societies and academic institutions in their development of programs 

to enhance management and leadership 

skills in women scientists.

Professional Visibility of Women

• Encourage NIH to increase the participation of women and minorities at all levels 

of NIH, e.g., study sections, advisory 

groups, and conferences. 

• Encourage academic institutions to place 

more women on appointment and promotion committees as well as tenure 

committees. Ensure that women have 

visible teaching roles, e.g., lectures, 

grand rounds presentations.

• Encourage journals to include more 

women on their editorial boards.

Mentoring

• Define, facilitate, and reward mentoring.

• Require the principal investigator of every 

funded RO1 grant to make a commitment 

to mentoring of junior faculty included 

in the grant.

• Incorporate into the criteria of judging 

applications for grants and contracts a 

component of mentoring and outreach. 

• Encourage collaboration among NIH, 

academic institutions, and professional 
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societies to develop programs for training 

mentors (with NIH support) and to adopt 

the most successful models of mentoring. 

• Encourage NIH to include in its own workshops a session that focuses on development 

of mentoring skills. 

Cultural Issues and Social Norms

• Fund a study of the cultural and sociologic 

aspects of being a woman in biomedical 

science careers to see how these beliefs 

impact on the success of a woman’s career.

• Study the different definitions men and 

women may use to describe work.

• Encourage NIH and other institutions to 

recognize legitimacy of different work styles, 

if the output is identical.

• Develop a survey to document the work 

styles of men and women and analyze for 

correlations with advancement in biomedical

careers (hours at work vs. productivity).

• Introduce educational programs to educate 

scientific community about harassment and 

discrimination as it affects all women and 

minority scientists, but particularly trainees.

• Encourage NIH to convene a conference to 

study how social norms impede the careers of

women scientists. This conference would focus 

on factors that discourage entry or retention of

women at all levels in biomedical careers.

• Incorporate in NIH grants enough flexibility 

to accommodate the transient but compelling

needs of women around issues of childbearing.

Note: Although the entire set of recommendations is intended to apply to all women, including

women with disabilities and special populations of

women, special comment is in order to acknowledge

the requests of the disabled workshop members for

special accommodations at meetings. Needs for 

special hotel accommodations, transportation 

between conference sites, access to meeting rooms, 

and appropriate seating arrangements should be 

recognized in all NIH meetings as well as other 

scientific and medical meetings.

References

1 Office of Research on Women’s Health. Woman in 

Biomedical Careers: Dynamics of Change: Strategies 

for the 21st Century, NIH Publication No. 95-3565,

Department of Health and Human Services, 1995.

2 Bickel J, Croft K, Johnson D, Marshall R. Women in 

U.S. Academic Medicine Statistics 1997, Washington, 

D.C.: American Association of Medical Colleges, 1997.

Selected issues in Research Design

HEALTH OF SPECIAL 

POPULATIONS OF WOMEN

S pecial populations” includes women of 

different racial, ethnic, and cultural origins;

women with disabilities; lesbians; women 

living in urban and rural settings; and immigrants,

among others. In this report, studies dealing with 

different racial, cultural, and ethnic groups are cited

primarily, but health issues for women in the other 

categories should not be forgotten. 

Any one of several data books demonstrates 

differences in health status and health outcomes 

among different populations of women. Whereas 

heart disease and cancer are the leading causes of 

death for all American women, cancer is the leading

cause of death for Asian women. Cerebrovascular 

disease is the third leading cause of death for white,

black, Asian, and Hispanic women; for American 

Indian women, however, the third leading cause is

accidents and unintentional injuries.1 Death rates 

from cancer vary among the different populations. 

For example, the death rate from breast cancer 

reported for black women is 31 per 100,000, 

whereas American Indian women in New Mexico 

are reported to have the lowest incidence with 

a death rate of 9 per 100,000.

Interpretation of the data from the source 

books and from epidemiologic and other types 

of research requires an understanding of how 

special populations are defined. Definitions vary 

among the sources of data. For example, although,

beginning in 1976, the Federal Government data 

systems classified individuals into the following 

groups — American Indian or Alaskan Native, 

Asian or Pacific Islander, black, and white — some

source books classify Pacific Islanders with American

Indians. Prior to 1980, the race of a newborn infant

was determined by the race of the father when 

neither parent was white. If the parents were of 

different races and one parent was white, the child 

was classified according to the race of the nonwhite

parent. Since 1980, the race of a newborn infant 

has been recorded according to the race of the 

mother. Persons of Hispanic origin are defined 

as persons speaking Spanish or with Spanish 

surnames, and may be of any race.

Given the variables associated with designation 

of race, culture, or ethnicity, one might question

whether using these designations to examine different populations for study is wise. Should individuals

be assigned to certain study groups according to 

such designations, or should they be assigned based 

on self-description? Agreement is needed among

researchers on a uniform method, so that sound 

comparisons can be made.

DIFFERENCES IN

HEALTH STATUS

Differences in health status and health outcomes among the different populations are known 

to correlate with educational, cultural, and behavioral

variables; individual preference; availability of services;

differences in treatment of disease; and differences in

Gloria E. Sarto, M.D., Ph.D.

University of New Mexico 

School of Medicine 

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“
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

supplementary services. However, physiologic and

pharmacokinetic differences and predisposition 

to certain disorders may explain some of the differences as well. Analysis of data over a 24-year period

showed that corpus uterine cancer among nonHispanic white women was twofold higher than 

for Hispanic women and three times higher than for

American Indian women.2 In this study, as in many,

race and ethnicity were self-reported. Prolonged 

exposure to endogenous or exogenous estrogens 

and obesity are risk factors for uterine cancer. 

Although the prevalence of exposure of the three 

ethnic groups to exogenous estrogen replacement 

therapy is not known, obesity is more common 

among both Hispanic and American Indian women

and thus exposure to high levels of endogenous 

estrogen could be presumed more prevalent. Diabetes and hypertension, which are risk factors for 

uterine cancer, also are more prevalent in Hispanic 

and American Indian women in New Mexico. These

assumptions conflict with the lower incidence rates 

of uterine cancer in these two groups. Further 

research should explore instances such as this.

The rate of cervical cancer among Hispanic 

women in the southwest was found to be almost 

twice that of non-Hispanic white women. Risk factors including lower income, low education level, 

and infection with multiple human papilloma virus

(HPV) types were similar for both groups, but for 

Hispanic women, infection with HPV types 16-18 

was strongly associated with cervical dysplasia. 

The odds ratio for a cervical lesion for non-Hispanic

white women was 18, whereas for Hispanic women 

the odds ratio for developing cervical dysplasia 

was 171. This disparity suggests that environmental,

immunologic, or genetic cofactors may play a part 

in the development of cervical dysplasia pathology 

and progression to invasive cancer.

In humans, a specific class of human leukocyte

antigen regions is associated with a variety of diseases,

including some cancers. This prompted researchers at

the University of New Mexico to look for an association

of an HLA phenotype with invasive cervical 

carcinoma in a group of New Mexico Hispanic

women.3 The investigators found that DR-13 haplotypes are associated with a strong protective effect

against developing invasive cervical carcinoma. On 

the other hand, a group of DRDQ haplotypes was 

associated with a strong susceptibility to develop 

invasive cervical carcinoma in association with 

HPV-16 infection. These results suggest that the

immune response to HPV-16 may be determined 

in part by specific HLA class II haplotypes and 

may influence risk of cervical neoplasia. In other

words, specific host genotypes may predispose 

some populations to certain cancers.

Virtually all comparative black/white studies 

in North America have shown that black women 

have 5 to 10 percent greater bone mass and 5 percent greater bone density than white women when

matched for age.4 This is the case despite the fact 

that blacks have been shown to have a significantly

lower calcium intake throughout the life cycle. 

Two possible explanations have been proposed to

explain the black/white difference in bone mass. 

One deals with calcium and bone metabolism 

and the other with reproductive hormones. A study

showed lower urinary calcium excretion among 

black children compared with white children of 

the same age. Lower urinary calcium excretion 

also was found in a population of older black 

women compared with white women. Although 

not fully explained, the concept is that lower bone

turnover among blacks may contribute to accumulation of greater bone mass. The implications of 

the differences in steroid hormone levels are not 

entirely clear, but it is hypothesized that higher 

estrogen levels among black pubertal girls favor 

retention of minerals by the skeleton, which is 

beneficial because of the lifetime priming of bone 

estrogen receptors. Thus, in this instance a physiologic explanation appears to account for some 

of the differences, although genetic determinants 

that increase bone mineral density — independent of

dietary intake of calcium — may be a factor as well.
“. . . my life as a disabled woman will shed some

light on this important topic. . . I continue to forge

ahead and tackle each day’s challenges and obstacles

head on. Yes, there will be detours along the way. 

That is a given circumstance and also my challenge.”

Mary Hepburn

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Bone mineral status among Asian populations 

has been studied only recently. There is some 

indication that bone mineral content and bone 

mineral densities are similar in Asian and white 

children. Japanese women are thought to have 

lower calcium intake, yet for elderly Japanese 

women living in Japan, hip fracture rates are 

significantly lower than for Caucasians living in 

the United States. For Japanese women in this 

country, the prevalence of hip fracture approaches 

that of white women. The degree to which acculturation and changing lifestyles affect health 

should be determined.

A common belief is that incontinence and 

pelvic organ prolapse occur less frequently among

black women than among white women. Until 

the NIH consensus development panel on urinary

incontinence in adults in 1989 emphasized the 

importance of gathering data regarding incontinence in nonwhite ethnic groups, most studies 

of incontinence were done on white women. In 

1993, a group of black women with incontinence 

were studied, and the findings were compared 

with those of a group of white women.5 Urodynamic

assessments showed that black women were more 

likely than whites to have motor instability as a 

cause of their incontinence and less likely to have 

genuine stress incontinence. Thus, black women 

presenting with incontinence require more accurate

and sophisticated urodynamic testing before they

undergo treatment. Continued study of a larger 

population and of different subgroups is needed. 

The fact that blacks have a greater prevalence 

of hypertension than whites is well known, but they

also have increased morbidity. Obesity is more common among black women than Caucasian women, 

20 percent of black women over the age of 18 are

smokers, and, as a group, black women are less 

likely to engage in regular physical activity, which 

puts them at greater risk. But there are physiologic 

reasons that increase risk and serious sequelae. 

Fifty-one percent of black women have undesirably high serum cholesterol levels and lipoprotein-A 

levels, which correlate with increased risk of coronary

heart disease. Diabetes is more prevalent among black

women. Blacks are more sensitive to sodium loading

and exhibit a less marked reduction in blood pressure

at night. The constant increased pressure load has 

obvious implications for the development of organ

damage and thus increased morbidity.

Differences in infant mortality rates have been

known for a long time. Elevated infant mortality 

rates have been attributed to adverse sociologic 

factors, including poverty, alcoholism, inadequate 

parenting skills, and inadequate prenatal care. 

But, even correcting for socioeconomic risk 

factors, blacks still have greater risk for infant 

mortality.6,7 On the other hand, favorable birth 

weight and low infant mortality rates have been 

reported more consistently for Hispanics of 

Mexican descent, despite the lower socioeconomic status. An explanation was that Hispanics 

of Mexican origin have a higher rate of fetal loss, 

which eliminates the biologically weaker fetuses. 

This does not seem to be the case, however. A 

study evaluating fetal deaths in Mexican American, black, and white non-Hispanic women 

who receive government-funded prenatal care 

did not substantiate an increased fetal death 

rate among Mexican-American women. Many 

think that the traditional family attitudes of 

Mexican-American women influence their 

health and the health of their newborn infants.
“Studies that investigate how exercise can promote

healthy aging in women are especially indicated.”

Andrew A. Guccione,

Ph.D., P.T.

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CULTURAL AND 

BEHAVIORAL 

DIFFERENCES

Maintaining health is essential for preventing 

disease. The roles of traditional cultural values and

sociologic and behavioral factors in health maintenance must be recognized. Among a group of 

women studied at Denver General Hospital, for 

example, the major reason for lack of prenatal 

care was attitudinal: Most pregnancies were 

unplanned, and feelings of depression, ambivalence about the pregnancy, and having to deal 

with other problems were the most common 

reasons cited for lack of prenatal care.8 Among 

the Hispanic women, a common reason for not 

getting prenatal care was, “I was getting good 

advice from family and friends.” Among blacks, 

the reasons were “I didn’t think it was important,” 

and “I didn’t want to think about being pregnant.”

White women were more likely to identify financial

reasons and problems with access than were black 

and Hispanic women. Nearly all women (88 percent) thought they were pregnant by the fourth 

month of pregnancy, but by the end of 6 months 

one-third still had not seen a professional.

Analysis of 19,027 females (56 percent black, 

44 percent white) showed that black women were 

less likely to exercise, more likely to be overweight,

and less likely to be nonsmokers.9 Explanations 

included lack of personal control over their lives 

and having to deal with a myriad of other issues. 

On the other hand, black women were more likely 

to obtain a Pap test and breast exam than white

women, which may be explained by the fact they 

commonly live in urban settings, where they are

screened when entering the health care system for

other reasons and where there is higher availability 

of medical services.

Hispanic women are less likely to obtain Pap

smears or to have had a mammogram in the past 

3 years.10 Access to care, the importance of a family

member to accompany them to the hospital setting,

transportation, and so on, play a role. The effect of

acculturation on health-seeking behavior has been

examined. A group of Mexican-American women 

age 40 or older living in El Paso were studied to 

determine the effects of acculturation in cancerscreening behavior.11 Acculturation was measured 

by English proficiency, English use in the family 

setting, value placed on culture, traditional family 

attitudes, and social interaction. The researchers 

found that the strongest independent factor affecting mammogram screening was insurance, but 

after they adjusted for socioeconomic factors, a 

woman with a positive attitude toward traditional 

family values was more likely to have undergone 

a mammogram.

PROVIDER ATTITUDE

DIFFERENCES

One cannot examine differences in health 

outcomes among special populations of women 

without addressing physician attitudes and practice.

Several studies indicate that less than 50 percent 

of primary care physicians take a sexual history 

from patients. Failure to inquire about the possibility of abuse — physical or sexual — is frequent. 

There is ample evidence in the literature that 

many lesbians avoid medical care because of fear 

of discriminatory practice, thus decreasing the 

likelihood of obtaining routine screening. Cultural

insensitivity of providers has been implicated as 

a reason that women of color fail to receive 

health-promoting care.
“We want to be assured that diseases and 

ailments that so disproportionately affect minorities

and women — diabetes, hypertension, teenage pregnancy, low-birthweight babies, heart attacks, strokes,

sickle cell anemia, kidney failure — are given 

adequate attention and funding.”

Jann Primus, Ph.D.

Spelman College

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VOLUME 2

Attitudinal barriers toward individuals with 

disabilities remain. Women with developmental 

disabilities frequently are treated as children — 

because of an incorrect assumption that they 

cannot understand adult discourse.

Differing practice patterns may relate to 

patients’ race. One study found an association 

between race and likelihood of screening for diagnosis of hypercholesterolemia in an office-based 

family medicine residency training program in

Rochester, NY.12 Of the group with identified 

race or ethnicity, approximately 23 percent were

minorities, of whom 80 percent were black. 

Female sex, age less than 45, receiving Medicaid, 

not having insurance, and being a minority were 

associated with reduced likelihood of screening.

Minorities were less likely to have a diagnosis of 

hypercholesterolemia on the medical record even

though cholesterol levels were comparable to 

those of whites. The authors concluded that 

this underdiagnosis of hypercholesterolemia 

in minority patients suggests a difference in 

the behavior of health care providers toward 

white compared with black patients.

In another study, of a group of Medicare beneficiaries including 24 million whites and 2 million

blacks, the black beneficiaries and low-income 

beneficiaries had fewer visits, fewer mammograms, 

and fewer immunizations against influenza, but 

were hospitalized more often and had higher mortality rates.13 They also had higher rates of amputation of the lower limbs, suggesting that black 

beneficiaries were less likely than whites to have 

leg-sparing surgery and more likely to undergo 

amputation. The rates for angioplasty and coronary

artery bypass surgery were substantially higher 

among white than black beneficiaries. Although 

the authors invoked many reasons for these differences, including educational, cultural, and behavioral variables, individual preference, and differences 

in treatment of disease, other barriers to elective 

health maintenance care such as race, low income, 

and physician attitude may exist.

In summary, health status and health outcomes

vary among different populations of women. It is

important to explore the reasons for the differences 

and to utilize the knowledge to influence the health 

of women.

References

1 National Center for Health Statistics. Leading causes 

of death by race and ethnicity, 1993. Health, United 

States, 1995. Hyattsville, Md: Public Health Service, 

1996. p. 114.

2 Becker TM, Wheeler CM, McGough NS, et al. Sexually

transmitted diseases and other risk factors for cervical 

dysplasia among southwestern Hispanic and nonHispanic white women. JAMA 1994;271:1181.

3 Apple RJ, Erlich HA, Klitz W, et al. HLA Dr-DQ 

associations with cervical carcinoma show papillomavirus-type specificity. Nat Genet 1994;6(2):157-62.

4 Anderson JJ, Pollitzer WS. Ethnic and genetic 

differences in susceptibility to osteoporotic fractures. 

Adv Nutr Res 1994;9:129-49.

5 Bump RC. Racial comparisons and contrasts in 

urinary incontinence and pelvic organ prolapse. 

Obstet Gynecol 1993;81(3):421-5.

6 Kerr GR, Ying J, Spears W. Ethnic differences in causes 

of infant mortality: Texas births, 1989 through 1991. 

Tex Med 1995;91(9):50-6.

7 Guendelman S, Chavez G, Christianson R. Fetal deaths 

in Mexican-American, black, and white non-Hispanic

women seeking government-funded prenatal care. 

J Community Health 1994 Oct;19:319-30.
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8 Meikle SF, Orleans M, Leff M, et al. Women’s reasons 

for not seeking prenatal care: racial and ethnic factors.

Birth 1995 Jun;22(2):81-6.

9 Duelberg SI. Preventive health behavior among black 

and white women in urban and rural areas. Soc Sci Med

1992 Jan;34(2):191-8.

10 National Institutes of Health, National Cancer Institute.

Seer Cancer Statistics Review: tables and graph. Bethesda,

Md; 1989. NIH Publication no. 89-2789.

11 Suarez L. Pap smear and mammogram screening in 

Mexican-American women: the effects of acculturation. 

Am J Public Health 1994;84(5);742-6.

12 Naumburg EH, Franks P, Bell B, et al. Racial differentials 

in the identification of hypercholesterolemia. J Fam Pract

1993 Apr;36(4):425-30.

13 Gornick ME, Eggers PW, Reilly TW, et al. Effects of 

race on mortality and use of services. N Engl J Med

1996;335:791-6.
SEX AND GENDER 

DIFFERENCES

BACKGROUND

With the founding of the Office of Research 

on Women’s Health and the enacting of

the mandate that women and minorities

be included in clinical studies, NIH has responded 

to the issues raised about sex and gender in medical

research. The Food and Drug Administration (FDA)

has echoed this concern about gender in medical

research by changing its policy on the study and 

evaluation of drugs in women. These policy changes 

by NIH and FDA reflect the growing concern for

women’s health, and have also opened the door to

other issues regarding clinical studies, sex and gender

differences, and new approaches to medical studies. 

CLINICAL STUDIES

Designing Clinical Studies

The NIH guidelines are still evolving; many 

in the medical community view them as a starting

point in the discussion of sex and gender and clinical studies. For example, one issue mentioned by 

the working group concerned the implication of 

the semantics of the NIH guidelines on “inclusion” 

of women and minorities in clinical studies. That 

women and minorities should be included suggests

that it is appropriate to design a study with men 

as the major focus as long as women are included. 

This concept should be addressed more clearly to 

promote studies that are initially designed for women

or minorities. The point is not just to increase the

number of women in clinical trials, or even how 

to determine if women are eligible for trials; rather, 

the point is what is being studied, the nature of 

how the experimental groups are being determined,

and how drugs and devices are being tested. The

design of the research study must derive from 

the question being asked. Designs will differ 

according to the questions being asked — for 

example, whether there is a difference between 

men and women in response to a drug and 

whether the drug works in women. Even when 

women are included in clinical trials, the data 

may be aggregated in such a way that investigators analyze the data overall and not by sex. 

Many researchers have noted that politics can 

prevent or hinder the study of sexual differences 

in clinical trials. For example, until recently, it was 

difficult to publish a paper with the words “sex differences.” The paucity of studies on neuroendocrine

aspects of female functions may be attributable 

to a belief that it was not politically correct to 

acknowledge different functioning at different 

times of the month or to a fear of discrimination 

based on the differences. 

Socioeconomic factors applicable to women 

can complicate research design. Socioeconomic 

differences cannot be measured in the same way 

in men and women because there are no good sexand gender-neutral measures of socioeconomic status.

Three basic measures of socioeconomic status are

income, occupation, and education. These factors 

Cochairs

George W. Counts, M.D.

National Institute of Allergy and Infectious Diseases

National Institutes of Health 

Otis Brawley, M.D.

National Cancer Institute

National Institutes of Health 

Rosalie Sagraves, Pharm.D.

University of Illinois at Chicago

Rapporteur: Carollyne Hutter

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tend to correlate better in men than in women. 

A woman can be highly educated, have a low 

household income, and be in a pink-collar job. 

Finally, there is a lack of studies on healthy 

people, an area for which research designs must be

unique to healthy women. For example, the effects 

of the menstrual cycle on drugs and other therapies

should be analyzed in clinical trials. 

Although incorporating women into the designs 

of clinical studies may create logistical issues, it may

result in new areas of research, innovative research

designs, and cost-effective options. A well-designed

and well-conducted study involving women and

minorities can provide information about treatment

and care of direct benefit to men and women alike. 

In addition, results from such studies can enable 

policymakers to make decisions that will improve 

the overall health of the nation. 

Balancing Research Cost While Asking Clinically 

Significant Questions

Adding sex and gender issues to a biomedical

study can considerably increase study costs, at a 

time when pharmaceutical companies and grant 

agencies are cutting costs. “All of our costs in industry

have been cut, are being cut, and will be cut in the

future. What this means is that any increase in cost 

in any area of drug development will be carefully 

considered.”1 Although the inclusion of women as

research subjects may initially cost more, the savings

will be realized in the longer term. Excluding women

from trials would result in inadequate data, which

could lead to inappropriate treatment, added risks 

for women, and increased costs to society. 

How can clinical trials be conducted at minimum cost and still include women participants? 

One possibility is for investigators to do multiinstitutional, collaborative studies. Another possibility is for investigators to ask smaller questions 

and be willing to be patient to get meaningful 

answers. The focus of research should be on 

clinically significant questions, and the answers 

will change how health care providers take care 

of their patients, whether women or men. 

The medical research community is currently

examining the role of managed care organizations

(MCOs) in women’s health research. Because large

numbers of people use the services of MCOs, an 

extensive pool of data is potentially available to

researchers. However, the role of MCOs in women’s

health research is more extensive than just as a data

source — MCOs could significantly affect clinical

research in general.2 At the Society for the Advancement of Women’s Health Research Annual Corporate

Advisory Council Conference in 1996, attendees 

generally agreed that MCOs could have a negative

effect on traditional clinical efficacy research because 

of financial, political, and operational concerns. 

These concerns require that knowledge be practical

and that practicality be incorporated into research

design, costs, measurement, and potential application.2 MCOs that perceive research as increasing 

costs, rather than generating profits, have been 

reluctant to become involved in research.2 The 

trend of MCOs and women’s health research is

“improved processes for providing care, but 

reduced technologies for implementing cures. 

The challenge for the research advocacy community will be to ensure the former without 

sacrificing the latter.”2

Recruiting and Retaining Women in Clinical Trials

Unless the appropriate women, in sufficient 

numbers, participate in clinical trials, the base of 

biomedical knowledge about specific conditions 

and diseases will always have major gaps. For 

example, women generally do not use the health 

care system for menopause, unless they need a 

hysterectomy. This absence creates difficulties 

for capturing an accurate picture of women and

menopause, and is one of numerous barriers to

addressing the health issues of women: “Access 

to health care, mistrust of the medical system, 

language barriers, cultural beliefs, and even transportation and child care are all issues that must 
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be addressed to ensure that women are able and 

willing to participate in clinical studies.”3

Designing research models to include women 

in clinical studies presents new questions about how 

to recruit women. The recruitment techniques that 

are used for men may not be effective for women. 

On some occasions, when pharmaceutical companies

opened trials to women, they did not come forward 

to participate. In such cases, investigators may be

inclined to assume that women do not wish to participate and may wish to proceed with the trial as

before. Thus, there is a need to train investigators 

to use different strategies to increase women’s participation. For example, typically the first step in 

recruiting potential participants is to advertise in 

newspapers. Whereas newspaper advertisements 

may be effective in recruiting men, studies indicate 

that women are more likely to respond to radio 

messages or television advertisements. In recruiting

women for some AIDS trials, investigators found 

that they had to offer incentives, such as transportation and day care, to enable women to participate.

Informing the appropriate people is key to 

recruiting for clinical trials, and yet two major considerations are often overlooked. First, although 

physician referrals can be crucial to successful 

recruitment, many physicians are not informed 

about clinical trials. Second, if the potential population to be recruited includes women whose native

language is not English, the recruitment plan should

include disseminating information in languages 

other than English.3

Once informed about a study, whether a 

woman decides to participate may depend on their 

attitudes toward the medical profession, research 

team members, and clinical studies in general. Participants’ confidence in those conducting the research,

and even their opinions about the quality of study

design, can be important determinants of enrollment

and retention. The recruitment and implementation

plans should consider establishing one-on-one 

relationships between research staff and study 

participants, having as many women as possible 

be members of the clinical staff, encouraging joint 

decisionmaking and informed consent, and establishing educational and support networks of former 

and current study participants.3

The relation between the research institution 

and the community participating in the study should

be considered when recruiting participants. Clinical

studies may fail if the researchers and community do

not have common goals or a shared recognition of the

needs of the community. Trust should be established

between the research institution and the community,

along with a partnership approach. Partnerships can 

be established by having members of broad-based

groups, such as religious groups, participate as early 

as possible in the recruitment process, preferably at 

the planning stage. Partnerships that create strong 

personal relationships between participants and 

clinical staff can lead to such benefits as higher 

participant retention and compliance with study 

protocols: “An attitude of caring and assistance 

on the part of investigators and staff may keep 

participants returning to the facility not only to 

participate in the study, but also for the personal 

and social contacts.”4

When recruiting and retaining women in 

clinical trials, investigators need to consider all 

the above-mentioned concerns, but these concerns should not be viewed as absolute obstacles 

to having women participate in studies — the 

obstacles can be overcome with careful planning 

and persistent efforts. 

Ethical and Liability Considerations

A major ethical and liability consideration 

is the inclusion of women of childbearing age 

in clinical trials. In particular, pharmaceutical 

manufacturers worry that including women of 

childbearing potential in clinical trials can make 

manufacturers vulnerable to lawsuits. The NIH and 

FDA guidelines address this issue. In 1993, the 

FDA reversed its recommendation that women 

of childbearing potential be restricted from 
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participating in drug trials. FDA issued new guidelines about including both sex and gender in drug

development, analyzing clinical data by sex and 

gender, assessing potential pharmacokinetic and 

pharmacodynamic differences between sex and 

gender, and conducting specific studies in women. 

It should be noted that excluding women does not

exempt manufacturers from liability risks; the manufacturers are still responsible for knowing how 

pharmaceutical agents affect women. 

Scientists, pharmaceutical companies, and 

the FDA emphasize the problems of testing pharmaceutical agents in pregnant women. They are 

concerned about protecting fetuses from potential 

toxic therapies as well as the possibility of liability 

and lawsuits.

During pregnancy, physiological changes 

occur in the cardiovascular, renal, gastrointestinal, 

pulmonary, and hepatic systems. These changes 

can affect how a drug is absorbed, distributed, 

metabolized, and eliminated. According to a white

paper by the American College of Clinical Pharmacy,

pregnancy significantly influences the pharmacokinetics, and possibly pharmacodynamics, of 

various compounds.5 The fetus and placenta 

should be regarded as different compartments 

in the pharmacokinetic model in pregnant women. 

Although pregnant women have been excluded

from clinical trials in the past, they use drugs during

pregnancy. Companies have marketed drugs used 

by pregnant women without having knowledge 

about the maternal and fetal effects of the drugs. 

An Institute of Medicine report states that 75 percent of pregnant women use prescription and 

over-the-counter medications.6 In 1992, investigators discovered that pregnant women with 

hypertension who used angiotensin-convertingenzyme inhibitors during the second and third

trimesters sometimes experienced fatal neonatal 

renal problems.7

The FDA is examining the issues surrounding 

participation of pregnant women in clinical trials 

of new drugs and biological agents. The agency has

acknowledged the importance of including pregnant

women in trials that use experimental therapies for 

life-threatening conditions, such as new therapies 

for AIDS. New models are needed, including animal models, and followup procedures, such as 

postmarket surveillance for drugs.

Animal Studies

Research on animals can lay the foundation 

of progress toward developing research designs 

for clinical trials, yet female animals are generally 

not used in research because of the rate and complexity of the estrous cycle. Few animal models 

mimic the menstrual cycle and when they are 

used it is almost exclusively for contraceptive 

research. Otherwise, if a study uses female animals, 

the animals are basically “castrated” before being 

studied. Investigators should investigate the use 

of female as well as male animals and differences 

in the hormonal milieus in these animals and 

consider looking at several animal models, not 

just a rodent model. 

SEX AND GENDER 

DIFFERENCES

Women and men are obviously different 

in regard to the presence of hormones, such 

as testosterone, estrogen, progesterone, and prolactin. Since these hormones affect sex- and genderdependent physiological characteristics, they may 

also modify the pharmacokinetics and pharmacodynamics of selected drugs. Yet the scientific 

knowledge base does not provide information 

about sex and gender differences in responses 

to drugs. It is vital that investigators determine 

under what conditions sex and gender differences 

happen and design clinical studies appropriately 

to examine these situations. 
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Women and men also differ biologically in 

body composition, size, and metabolism. These 

factors may influence the dosage, disposition, and

metabolism of drugs. Therefore, when determining

drug dosing it may be appropriate to consider these

differences, especially body size and composition,

instead of using standard fixed doses. 

The design of diagnostic technology and medical devices poses concerns. Most medical diagnostic

technology is built with a man in mind; and, because

some medical devices are designed for men, women 

are often too small for the use of the devices. 

Differences between women and men are more

than just biological. There are also behavioral and 

psychosocial differences between the sexes. Differences in lifestyle, such as exercising, alcohol consumption, and cigarette smoking, affect health. 

Women and men perform different roles in society,

which influence their health. Women are more 

often the victims of domestic violence and have 

higher rates of depression and eating disorders. 

Another important sex and gender issue is 

aging. On average, women live 7 years longer 

than men; they constitute the majority of the 

population over 65.6 Therefore, research on the 

aging process should include women. Women 

and men are affected by different diseases and 

conditions. Rheumatoid arthritis and osteoporosis 

are more common among women than men, 

whereas more men than women suffer from gout. 

In addition, older women tend to experience more

adverse reactions to medications than do men.6

In 1994, the Institute of Medicine Committee 

on the Ethical and Legal Issues Relating to the 

Inclusion of Women in Clinical Studies concluded 

that sex and gender differences are relevant to 

design of clinical drug trials. They summarized 

that “differences in size, fat ratios, and metabolic 

rates are associated with differences in drug concentration, metabolism, and response. Psychosocial 

differences are associated with differences in risk 

factors and, more important, in adherence to 

experimental protocols. These differences can 

change over time, both in the short term (during 

menstrual cycle) and the long term (with pregnancy,

lactation, and aging).”6

LONGITUDINAL AND

LIFE PHASE RESEARCH

Because of the unique role that female hormones play in women’s lives, women go through 

various stages based on hormone support. These 

stages influence the development of diseases such 

as myocardial infarction and osteoporosis. Thus, 

a study in which only premenopausal women 

participate may not reveal findings that are applicable to postmenopausal women. If women participate in pharmacokinetic and pharmacodynamic 

studies, it is vital to establish whether they are 

premenopausal or postmenopausal and whether 

they are receiving hormone replacement therapy 

or oral contraceptives. 

It is essential to conduct studies that include 

and describe the different phases of a woman’s life, 

and to classify women by the menopausal stage,

instead of by age only. This was not done in breast 

cancer screening trials. In these trials, women 

were grouped by age, instead of by pre- or postmenopausal status. 

Research designs and study instruments 

should be developed that describe the menstrual 

cycle longitudinally and assess hormone differences

across menstrual cycles. Clinical trials that include 

premenopausal women should study changes not 

only month to month, but also week to week, plotting information over two or three menstrual cycles. 

A single blood level is not helpful, because it represents a single point in time, instead of a view of

dynamic change. New technologies may be needed 

to perform population-based studies: instead of 

blood measurements, investigators should explore 
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less intrusive measures such as those using saliva 

and urine samples. 

INSTITUTIONAL 

REVIEW BOARD 

SHOPPING

Before conducting research, some pharmaceutical companies go “institutional review board 

(IRB) shopping,” looking for the appropriate IRB 

for the investigation. IRBs may find equitable selection criteria confusing if the private and public 

sectors present conflicting policies. Sometimes IRBs 

get requests from pharmaceutical companies to do

research that specifically excludes women. When 

an IRB questions a protocol or tells a pharmaceutical

company to change the protocol to allow women in 

the studies, the company may threaten to take their

studies elsewhere. Money for research is at such a 

premium that if a pharmaceutical company has any

conflict with an IRB, the company can move the 

study elsewhere.

To deal with IRB shopping, IRB chairs have 

proposed establishing a network of IRBs so that 

IRBs can communicate with each other to stay 

abreast of pharmaceutical companies’ studies 

and activities. Another way to avoid IRB shopping is to have pharmaceutical companies contribute to a pool of funds (perhaps managed 

by NIH), which would separate research money 

from pharmaceutical companies’ perspectives. 

Such a pool could also be established with 

funding from MCOs. 

Another concern with IRBs is that the boards 

do not learn about the population composition 

of the study until the annual or interim project 

review, which restricts an IRB’s capability to secure 

a balanced population study. Involving IRBs in 

the early design phases of research would help 

to ensure that there is an equitable representation 

of study subjects.8

IN SEARCH OF A 

NEW PARADIGM

In 1995, Gerhard Levy wrote about patientoriented pharmaceutical research that focuses on 

the individual. This research would extend beyond

pharmacokinetics, pharmacodynamics, and medication adherence to include the behavioral sciences.9

In a similar vein, the World Health Organization’s 

Tropical Diseases Research program uses a multidisciplinary approach that views women’s health 

as a result of sociocultural interactions and 

economics.10 A framework for health research 

is supported that would create a sex and gender 

framework that incorporates research from such 

diverse fields as medicine, pharmacy, public health,

epidemiology, anthropology, economics, entomology,

agriculture, environmental engineering, ecology, and

health education. In this approach, women and 

men are seen as principal agents of their own health,

with personal needs, priorities, and preferences. 

EDUCATION

The issues discussed above all require education. The general public needs to learn more about

women’s research issues and about participating 

in clinical trials; pharmaceutical companies about 

inclusion of women in trials; and investigators 

about how to design trials for women’s participation, and how to create new research models 

based on women. Moreover, society, the medical establishment, and investigators should be 

educated on the importance of having more 

women investigators. 

CONCLUSION

Scientists will continue to struggle with the 

fact that they serve a diverse society — diverse in 

sex, size, age, culture, and income. The population 

is not only diverse, but dynamic. Given the nature 

of society, it is vital to recruit, retain, and observe
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diverse populations in an ethical manner. The public

needs to be informed and educated about medical

studies and their importance. Ultimately, scientists

must search for the most significant findings, those 

that will affect the practice of medicine. Part of 

science’s responsibility is to serve all; yet science 

must also focus on the most meaningful issues, 

and not be diverted by simplistic academic issues. 

References 1 Bush, J. The industry perspective on the inclusion 

of women in clinical trials. Academic Medicine 

1994;69:712. 

2 Moore D, Bernard S. The impact of managed 

care on women’s health research. J Women Health

1996;6:197-202.

3 Kaufman B, Rodriguez-Trias H. Participant and 

community issues in the recruitment and retention 

of women in clinical studies. In: Recruitment and 

Retention of Women in Clinical Studies. NIH Pub. 

No. 95-3756. Office of Research on Women’s Health,

National Institutes of Health, 1995. p. 17-19. 

4 Kuller LH. Current experiences in women’s health research. In: Recruitment and Retention of Women 

in Clinical Studies. NIH Pub. No. 95-3756. Office 

of Research on Women’s Health, National Institutes 

of Health, 1995. p. 27. 

5 Sagraves R, et al. Women as research subjects. 

American College of Clinical Pharmacy White Paper. 

Pharmacotherapy 1993;13:534-42.

6 Mastrianni A, Faden R, Federman D, eds. Women and

health research: Ethical and legal issues of including

women in clinical studies. Washington, D.C.: National

Academy Press, 1994. p. 93. 

7 Merkatz R, et al. Women in clinical trials of new drugs. 

N Engl J Med 1993 (Jul 22);329:295. 

8 Henderson M, Lee MM. Investigator and institutional

issues in the recruitment and retention of women 

in clinical studies. In: Recruitment and Retention of 

Women in Clinical Studies. NIH Pub. No. 95-3756. 

Office of Research on Women’s Health, National 

Institutes of Health, 1995. p. 11, 14. 

9 Levy G. Patient-oriented pharmaceutical research: 

Focus on the individual. Pharm Res 1995;12:943-4. 

10 Rathegeber E, Vlassoff C. Gender and tropical diseases: 

A new approach. Soc Sci Med 1993;37:513-20.

RACIAL, ETHNIC, AND

CULTURAL DIVERSITY

BACKGROUND

A merican women come from and continue 

to live in diverse racial, ethnic, cultural, 

and socioeconomic backgrounds. A growing

number belong to groups commonly referred to as

minorities — black, American Indian, Alaskan Native,

Asian, Pacific Islander, Hispanic. To a large extent, a

woman’s health status may depend on the group or

subgroup to which she belongs, as is apparent in 

the following statistics:

• In 1993, life expectancy at birth was 79.5 

years for white women and 73.7 years for 

black women.1

• In every year from 1970 to 1993, heart disease 

was the leading cause of death for all women 

living in the United States. However, between 

1970 and 1980 the age-adjusted death rate for

heart disease was about 50 percent higher for 

black women than for white women. Between

1980 and 1993, the heart disease mortality 

differential between white and black women

widened to 67 percent, due to a more rapid 

decline in heart disease death rates for white

women (26 percent) than for black women 

(18 percent).2

• In 1993, the age-adjusted death rate from 

heart disease was 24 percent lower for American Indian and Alaskan Native women and 

43 percent lower for Asian and Pacific Islander

women than for white women (99.3 per 100,000),

and the rate was 29 percent lower for Hispanic

women than for non-Hispanic white women.2

• In 1993, black women were 28 percent more 

likely than white women to die of breast cancer.3

• Since 1973, the age-adjusted incidence rate 

for ovarian cancer, the most common female 

reproductive malignancy after breast cancer, 

has been about 50 percent higher among 

white women than among black women.4

• Most of the women diagnosed with AIDS 

during the 12 months ending June 30, 1995, 

were black or Hispanic women (59 percent 

and 17 percent, respectively).5

• Between 1988 and 1991, the age-adjusted 

prevalence of hypertension was higher for 

non-Hispanic black women (31 percent) than 

for non-Hispanic white women (21 percent) 

or Mexican-American women (22 percent).6

• Between 1988 and 1991, being overweight 

was more common among women whose 

family incomes were below the poverty line 

than among those with higher incomes. 

Among all women 20 years of age and over, 

the age-adjusted prevalence of overweight 

was 47 percent for women below the poverty 

line and 32 percent for those at or above the

poverty level.7

Cochairs

Virginia S. Cain, Ph.D.

Office of Behavioral and Social Sciences Research 

National Institutes of Health

Helen Rodriguez-Trias, M.D.

Pacific Institute for Women’s Health

Western Consortium for Public Health

Rapporteur: Wanda Avila

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• In 1992-93, women were 6.6 times as likely 

as men to experience violent crimes by a spouse,

ex-spouse, or partner. However, the rate of violent attacks by intimates among women in 

families with annual incomes of less than 

$10,000 was 19.9 per 1,000 women, compared with 4.5 per 1,000 women among those

with annual incomes of $50,000 or more.8

• In 1993, women below the poverty line were 

3.2 times as likely to be uninsured as women

above the poverty line (36 percent and 11 percent, respectively).9

• In 1993, women who lived below the poverty 

line were 57 percent more likely to lack a regular

source of medical care than women whose family

income was at or above the poverty line (16 percent and 10 percent, age-adjusted).10

• For women admitted to substance abuse treatment in 1993, the type of substance abuse 

correlated with race and ethnicity. Alcohol, 

and alcohol combined with another drug, 

were the primary substances of abuse among 

non-Hispanic white women, while cocaine 

was the predominant substance of abuse 

among non-Hispanic black women, and 

heroin among Hispanic women.11

Despite these and other statistics that clearly 

indicate the disparities in health status among various subpopulations of women, clinical research that

has included women at all has focused on white, 

middle-class, heterosexual, able-bodied women. 

This focus on the majority group retards the advance 

of biomedical information about minority groups, 

who make up more than 25 percent of the population

in the United States (see Table 1), and who are different not only in biological factors but also in cultural

and behavioral factors that are associated with health.

The percentage of minority groups in the population 

is increasing and the disparity between the health 

status of the majority group and that of minority

groups in some cases remains large.12

To develop the knowledge base that will yield 

benefits for minority women, enabling them to 

access the remarkable advances in medicine and 

health care, population diversity must be ensured 

in all aspects of research, including training minority researchers, awarding grants for research that

includes diverse populations, designing research 

models to evaluate the differences among population groups, retaining study participants from 

diverse populations, and publishing results so 

that the appropriate caretakers have access to 

the information.

TABLE 1. Detailed Race and Hispanic Origin of U.S. Women, 1980 and 1990-1993, Numbers in Thousands

RACE/ORIGIN 1980 1990 1991 1992 1993

All Persons 226,546 248,710 252,177 255,078 257,783

Women

White 99,835 106,561 107,631 108,584 109,515

Black 14,046 16,063 16,412 16,653 16,925

American Indian and Alaskan Native 718 1,041 1,068 1,081 1,099

Asian and Pacific Islander 1,915 3,805 4,087 4,279 4,444

Hispanic 7,329 10,966 11,460 11,871 12,405

Source: National Center for Health Statistics: Health, United States, 1995.
“Each ethnic group has certain values, beliefs,

symbolic meanings, and sense of spirituality that 

guide our family, close interpersonal relationships,

choices, and decisions.”

Wes Sagawa

Hawaii—Caring for 

Women Project

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The study of the health problems in diverse 

subgroups could also increase the knowledge base

about how to prevent and survive disease, with 

applications for the entire population. Research 

models that study the assets on resiliencies of 

specific groups and individuals might reveal the 

adaptive mechanisms that make them healthy 

despite adverse environments. For example, the 

study of heart disease among Asian-American 

women, who have a much lower incidence of 

heart disease than women from any other racial 

or ethnic group, might provide insight into the 

resiliency factors and behaviors that protect from 

heart disease. An examination of beneficial dietary or exercise patterns might suggest preventive 

strategies for all women.

NIH GUIDELINES ON

INCLUSION OF WOMEN

AND MINORITIES IN

CLINICAL STUDIES

In the past 5 years, the National Institutes of

Health (NIH) has taken several steps to increase 

the participation of women and minorities in 

clinical studies. Most notably, early in 1994, the 

agency published its NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical 

Research, which require that researchers receiving 

NIH support include women and members of minority groups and their subpopulations, when appropriate, in biomedical and behavioral research projects

involving human subjects.13 NIH issued these guidelines in response to the NIH Revitalization Act of 

1993 (P.L. 103-43), which directed that “the Director

of NIH, in consultation with the Director of the Office

of Research on Women’s Health and the Director of 

the Office of Research on Minority Health, shall conduct or support outreach programs for the recruitment of women and members of minority groups 

as subjects in projects of clinical research.” The goal 

of this requirement is to increase the opportunities 

for obtaining critically important information with

which to enhance health and treat disease among all

Americans, and to detect and account for significant

differences between genders or racial and ethnic 

groups where they exist.

The guidelines also strengthened the previous 

policies published in the NIH Guide for Grants and 

Contracts, 1990, which required that NIH staff and 

peer advisory groups “ensure that applications/proposals for extramural support for clinical research 

studies involving human subjects include appropriate representation of women and minorities, unless 

a compelling justification is made for their exclusion or inadequate representation.”14 The guidelines

required NIH to take three additional actions: (1) to

ensure that women and minorities and their subpopulations are included in phase III clinical trials in a 

way that differences in intervention effect can be 

analyzed, (2) to reject cost as an acceptable reason 

for excluding these groups, and (3) to initiate programs and support for outreach efforts to recruit 

these groups into clinical studies.

ETHICAL ISSUES FOR

INSTITUTIONS AND

IRBS TO CONSIDER

The importance of including women and 

minority groups in health research must be balanced

against the right of individuals to refuse to participate in research. To facilitate that process in 1994,

NIH’s Office of Protection from Research Risks 

issued a report outlining the responsibilities of 
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institutions and institutional review boards (IRBs) 

that are responsible for protecting the rights of 

study participants in their consideration of ethical

issues surrounding the inclusion of women and 

minorities in research.15 The report lists seven 

key responsibilities:

1. To provide investigators with written guidance

clearly delineating expectations for inclusion of

both genders and minorities in the design and

conduct of research.

2. To specify that, when scientifically appropriate,

investigators show how the research will address

any difference in the way a health situation or

intervention in the proposed research may affect

one gender or minority group. Investigators 

should be prepared to describe the extent to 

which both genders and minority groups have

been involved in similar research.

3. To review the extent to which investigators 

are collaborating with researchers at other 

institutions to ensure representation and sufficient involvement of participants of both 

genders from minority groups. The review 

of such information is particularly important 

in phase III clinical trials.

4. To consider whether cash or material reimbursements are appropriate to the educational level 

and socioeconomic status of the study participants and to ensure that these reimbursements 

do not promote coercion or undue influence 

to participate or remain in the study.

5. To ensure that consent documents have been

translated appropriately or that translators are

available when the study participants include

speakers of foreign languages or those who 

are illiterate. 

6. To include women and members of minority

groups on the IRB, especially if the nature 

and volume of the research to be conducted 

at the institution routinely includes these 

populations. IRBs should also consider consulting ad hoc advisors who could help with

understanding the perspectives of various 

groups. Also, institutions and IRBs can encourage investigators to seek out such perspectives

during the planning of research protocols.

7. To require that NIH-supported investigators 

specify the gender and racial or ethnic composition of the subject population, as well 

as their criteria for including or excluding 

any subpopulation, or to provide a clear 

rationale for excluding such information 

from the background data for the protocol.

TRAINING OF MINORITY

RESEARCHERS

The diverse views that women and minorities

could bring to bear on the research agenda have 

been significantly absent. Diverse populations pose

diverse and challenging issues that can be better

researched and understood only by a creative 

variety of research approaches. Researchers who 

are homogenous in culture and experience are less 

likely to generate rich and varied research concepts

than researchers who are diverse. Many people 

believe that clinical research to date has focused 

on the health status of white men because most 

investigators are themselves white men. One of 

the best ways to improve the quality and quantity 

of research and alter its focus is to increase the 

number of women and minority investigators. 

An additional advantage to cultural diversity 

among researchers is the enhanced effectiveness 

of recruiting the participation of women from 

minority communities.

Since 1989, NIH has encouraged the training of minority researchers through such programs 

as its Minority Research Supplement Program, 

which provides supplements to minority high 

school and college students, graduate research 
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assistants, individuals in postdoctoral training, 

and investigators. In fiscal year 1990, NIH provided minority supplements to 376 members 

of ethnic groups: black (226), Hispanic (114), 

American Indian (20), Pacific Islander (10), 

and unknown (6).16

Collaborative programs between majority and

minority institutions can provide important training

opportunities for the students at both institutions. 

A program established between Tulane University 

and Xavier University, a black university in New

Orleans, provides a model for other institutions 

who want to increase the number of minority 

investigators. The two universities have established 

the Center for Bioenvironmental Research (CBR),

which investigates the causes and effects of 

environmental problems and devises practical 

solutions for them.17 One way in which the CBR 

fosters training for minority researchers is by offering fellowships to minority students of outstanding

academic achievement and scholarly promise who 

have been formally admitted to a doctoral program 

and whose research topic is environmentally related.

For the academic year 1996-1997, two minority

women were among the six recipients of fellowships.

Both women are graduate students in the molecular

and cellular biology program. One will study the 

identification of phytosterols that have anti-estrogenic

activity in breast and endometrial cancers. The second

will investigate mechanisms of lung injury induced 

by environmental agents such as air pollutants and

allergens.18 The CBR also provides opportunities 

for investigators to work with minority communities.

For example, CBR members provide an ongoing 

occupational health research and advisory function 

for the Southern Louisiana Industry Council, placing

special emphasis on minority health. CBR’s Coping

with Community Stressors Program examines minority community responses to environmental risks, 

and the Environmental Justice Partnership Project

addresses the environmental research, education, 

and outreach needs of community groups along 

the Mississippi River chemical corridor. Also, in 

cooperation with the U.S. Department of Housing 

and Urban Development, CBR members are working with residents of a public housing community 

in New Orleans to identify and act on environmental

health issues.

DESIGNING STUDIES 

TO INCLUDE MINORITY

WOMEN

In planning clinical research, the NIH guidelines encourage investigators to first consider whether

their scientific questions or hypotheses make the 

inclusion of minority women in the study appropriate. Investigators may limit the population to women

from a single minority group if their scientific questions or hypotheses apply to majority women as well,

and if the condition to be studied is more severe or

prevalent among a particular group of minority 

women than among majority women, or if less is

known about the disease or treatment in minority

women than in majority women.

For an NIH-defined phase III clinical trial, 

the investigator should determine whether important minority differences are to be expected in the

intervention effect. (NIH defines a phase III clinical

trial as a broad-based clinical investigation to evaluate an experimental intervention in comparison 

with a standard or control intervention or to compare two or more existing treatments.) If so, the 

investigator should design the trial so that the 

intervention effect can be tested for minorities 

or their subpopulations.

UNDERSTANDING THE

STUDY POPULATION

To obtain valid data, researchers must clearly

define the populations they are studying. Countries 

of origin, immigration status, level of acculturation,

socioeconomic status, and cultural and linguistic characteristics vary widely. A cultural or racial label for a

minority group may fail to reflect the heterogeneity 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

of individuals or groups to which the label is applied.

For example, the label “Southeast Asian” refers to

Philippine, Hmong, Laotian, Vietnamese, and Cambodian peoples, and the term “American Indians” 

is used to describe more than 500 federally recognized tribes. Similarly, “Hispanic/Latino” populations

include Mexicans, Puerto Ricans, Cubans, and other

Central and South Americans, whose ethnic origins

and racial characteristics are varied. Yet, health studies

on “Hispanics” commonly include a larger number 

of Mexican Americans (who constitute almost 65 percent of the Hispanic population in the United States)

than members of any other Hispanic subpopulation.

Generalizations based on data from these participants

may be valid for Mexican Americans, but invalid for

Hispanics of other origins.

An understanding of cultural and linguistic 

differences is essential to ensuring that methods 

used in screening and interviewing are culturally 

sensitive. For example, the Hmong have views 

regarding blood that prohibit its sampling. Some

groups take offense at questions about sexual issues.

One recent recruitment effort among black women 

students at Howard University failed because the

women thought that the questions about sexual 

behavior were inappropriate, and they simply refused

to answer them. In addition, important linguistic 

differences often exist among speakers of the same 

language who come from different countries; an 

inoffensive word for a Puerto Rican, for example, 

may be an obscenity for a Mexican.

COLLABORATION WITH

THE COMMUNITY

Successful research efforts in minority communities depend on collaboration with members 

of the community at every phase of the research. 

Community leaders and other residents, as well 

as the study participants themselves, should be

involved in setting research goals, designing appropriate methods for informing the target population

about the planned research, determining appropriate instruments for collecting data, and 

evaluating outcomes.

A major barrier to recruitment in many 

minority communities might be distrust of scientific researchers because of historical incidents of 

abuses of research by outside organizations and

researchers, or because they may feel that the

researchers have been insensitive to the health 

concerns of their community. Therefore, enlisting 

the support of community leaders may be essential 

to gaining access to a community. Researchers who

meet with community leaders to define the health 

or disease problems they want to study and to 

explain the benefits and risks of the research are 

likely to find that the leaders are eager to provide 

a perspective on the cultural, behavioral, social, 

and economic factors that may contribute to or 

interfere with the research protocol. The community leaders can also help researchers form 

networks with other community organizations 

that will facilitate development and acceptance 

of the planned research. 

Collaboration with religious leaders has been

found to be especially useful for several reasons. 

First, churches are usually interested in participating in primary prevention efforts, operating health 

care and wellness programs of their own. Also, since

churches serve as natural community centers, establishing the church as the place of contact between

researchers and participants partially eliminates the

transportation problems that constitute a barrier 

to participation in studies. Furthermore, churches 

tend to involve entire families. The importance of 

the family among many minority groups makes 

the inclusion of the individual’s family desirable 

in dealing with the individual’s health problems. 

For example, smoking cessation research shows 

that Latino men are more likely to stop smoking 

if they are encouraged to do so to benefit their 

wives and children. In the black community, too, 

a health care project is always a family project. 
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Ministers and other community leaders may 

also be able to help researchers gain access to those

populations who can most benefit from the research

effort, such as those minority women who never use

the health care system or who use it only at times of

crisis. Too often, researchers in minority communities

have had to select their samples from the people who

have access to health care, simply because they had 

no access to those who most needed health care.

Community leaders and other members can also

help define the problem to be studied, ensuring that

the priorities of the researchers pose no conflict with

those of the participants. For example, a community

concerned with alcoholism, drug abuse, and AIDS 

may have little interest in participating in a study 

on dietary cholesterol. 

Recruitment and retention efforts are much 

more likely to be successful if the recruiters are 

local residents of the same race and ethnicity as 

the defined study population. At one West Philadelphia clinic, for example, nurse practitioners are 

collaborating with the principal investigators from 

the university in a highly successful weight loss 

program for black women. Also, a study on how 

to reduce prenatal transmission of AIDS in southeastern Pennsylvania is using HIV-positive women 

as part of the investigative team. The researchers

trained the women how to gather data through 

personal interviews and telephone conversations. 

As a result, the women have a sense of accomplishment, and the project has reported a tenfold

improvement in access to information.

Local residents may also have better insight 

into the problems that are causing participants to 

drop out of a study. For example, researchers assume

that low retention is the result of child care and transportation problems, only to find out that the real reasons are quite different. Community residents may 

be able to suggest ways to retain participants in the

study, such as by setting up a network relationship

among the participants so that they will remind each

other to visit the clinic at the appointed time. 

GIVING BACK TO 

THE COMMUNITY

Researchers in minority communities have a 

moral obligation to give something back — whether 

that return be health care, education and training, 

or even employment. Several institutions have established programs that can serve as models for a 

reciprocal relationship between researchers and 

the communities in which they work:

• The Emory School of Nursing has opened 

clinics in so-called “undeveloped” poor 

neighborhoods. 

• At the University of Wisconsin, professors 

from the School of Nursing and health professionals donate their time on evenings and 

weekends to a community center. They also 

do intensive community education. In return, 

they ask the community to participate in their

research projects. 

• In setting up the Navajo Research Program 

in early 1996, an institutional review board 

was first established to ensure that researchers

would benefit the health of the Navajo people. 

The board asks researchers (1) to provide educational materials to help the people or the Navajo

service providers, (2) to train the Navajo staff in

existing health care facilities and programs, and 

(3) to return to the reservation when the research

is completed to explain the results of their studies

in layman’s terms and to explain the significance 

of those studies for the Navajo people.

PUBLICATION OF

RESEARCH RESULTS 

AND EXPERIENCES

Published research data should show results 

by gender and minority group status. In spite of the

general recognition of the importance of including

minority women as study participants, journals 

still frequently publish studies that give no information on the race or ethnicity of the populations 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

studied. For example, a recent survey of all the 

articles published in the New England Journal 

of Medicine in 1995 revealed that 80 percent 

of the articles gave no information on the race 

or ethnicity of the populations studied.

Biomedical science would also benefit from

increased reporting of research outcomes, successful and unsuccessful, involving minority groups.

Although many research institutions have developed

excellent relationships with minority communities,

they have not published these experiences, which

would be useful to other investigators. 

SOCIAL, CULTURAL,

AND PSYCHOLOGICAL

ISSUES

Clinical research is needed that takes into 

account the social, cultural, and psychological 

issues relevant to health, especially in the study of

health problems of minority women. More studies 

are needed on the ways that the cultural and social

environments of minority women, and their perceptions of these environments, influence their health 

and quality of life. Working group members felt 

that progress in minority health research depends 

on developing and applying research models 

that integrate quantitative and qualitative methods 

to study the social, economic, and biomedical 

determinants of health. A holistic approach that 

overcomes the false dichotomy between body 

and mind is needed. In that vein, a study of 

black working class women and black professional men conducted by epidemiologists at the 

Harvard School of Public Health and the Kaiser 

Foundation Research Institute found a link 

between hypertension and race, gender, and 

socioeconomic class, and between hypertension 

and the way in which an individual reacts to 

the perceived discrimination.19 More research 

of this type is needed to understand how the 

variables of race, class, and gender affect health.

RECOMMENDATIONS

The Working Group on Racial, Ethnic, and Cultural Diversity recommended the following ways in

which NIH can more effectively involve and benefit

diverse communities of women in research projects:

• Give peer review groups strict criteria to 

follow in reviewing grant applications and 

proposals, specifying requirements as to gender,

race, and ethnicity of study participants.

• Diversify peer review groups, ensuring that 

they include women and minorities.

• Encourage collaborative research with minority

institutions, states, and communities.

• Award more grants to minority women 

investigators.

• Examine the cultural and financial barriers 

to the participation of low-income populations 

in research.

• Increase the number of supplemental awards 

to minority students.

• Meet with journal editors to encourage them 

to require that clinical studies report data 

classified by race and ethnicity. 

• Encourage researchers to publish their 

experiences, successful and unsuccessful, 

in working with minority populations.

• Establish a clearinghouse for the publication of research experiences with minority populations.

• Relax guidelines for inclusion in studies so 

that potential participants are not excluded 

from studies because they have some disease 

or condition that makes them ineligible 

to participate. 
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• Encourage a more comprehensive approach 

to the study of health problems of minority 

women than the traditional medical 

model allows.

• Encourage the development of research 

models that study population assets and 

resiliencies that prevent disease and 

promote survival.

The working group also recommended the 

following ways in which investigators can more 

effectively involve and benefit diverse communities 

of women in research projects:

• Report data by gender and racial and 

ethnic categories.

• Analyze the data for their previously published

studies by gender, race, and ethnicity, and 

publish an addendum to the studies.

• Report experiences, successful and unsuccessful, working with participants from diverse 

racial, ethnic, and cultural groups.

• Design more studies that are homogeneous 

in terms of ethnic and racial groups in order 

to find out more about a particular group.

• Collaborate on research projects with researchers

who have access to other populations, using the

same variables. 

• Examine substance abuse and violence in the 

general population, not only in low-income 

populations.

• Design more studies to include two groups of

women who are now usually excluded from clinical studies: handicapped women and lesbians.

• Ask women within the community to collaborate

on projects by helping to identify the problem to

be studied, suggesting appropriate recruitment

strategies and methods of data collection, and 

participating in the analysis and interpretation 

of study results.

• Include the participants’ families in subgroups

where family is of great importance.

• Collaborate with community church groups in

planning, conducting, and evaluating research.

• Collaborate with churches on research in minority

communities where appropriate.

• Include the participants’ families when the participants belong to minority groups where family is 

of great importance.

• Reach out to those minority women who never

enter the health care system or who do so only 

at a time of crisis.

• Develop culturally appropriate instrumentation 

and outcome measures.

• Determine what participants themselves want to

achieve through participation in the study.

• Examine barriers to health care from the participant’s point of view, which may differ radically

from the researcher’s preconceptions as to what 

the barriers are.

• Use a qualitative rather than quantitative model 

of health care so that researchers can understand

the health care needs of the community and how

well they are meeting those needs.

• Establish in some situations community-based 

centers for research, much like the community 

centers that have been established for HIV 

and drug abuse.

• Find ways to give back to the community through

providing health care, education and training, 

and employment. 
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References

1 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 17.

2 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 21.

3 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 22. 

4 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 25. 

5 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 26.

6 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 34. 

7 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 39.

8 Bachman R, Saltzman LE. Violence against women: 

Estimates from the redesigned survey. U.S. Department of Justice, Office of Justice Programs, Bureau 

of Justice Statistics, 1995.

9 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 45.

10 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 46.

11 National Center for Health Statistics. Health, 

United States, 1995. Hyattsville, MD: Public 

Health Service. 1996. p. 55. 

12 Council of Economic Advisers for the President’s Initiative

on Race. Changing America: Indicators of Social and 

Economic Well-being by Race and Hispanic Origin. 

September 1998. pp. 4, 40.

13 NIH guidelines on the inclusion of women and 

minorities as subjects in clinical research. Federal 

Register, March 1994. 

14 NIH Guide for Grants and Contracts, 1990.

15 Office of Protection from Research Risks (OPRR). 

Inclusion of women and minorities in research. 

OPRR Reports 94-01, Bethesda, MD: OPRR.

16 Rene A, Fakunding J. Support of minority training and

career development in the biomedical and biobehavioral

sciences by the National Institutes of Health. In: Health

behavior research in minority populations: Access, design,

and implementation. Washington, D.C.: National Institutes

of Health. NIH pub. no. 92-2965. 1992.

17 Allen A. The synergy of Tulane and Xavier Universities.

Environmental Forum 1996;l,5; no 1. 

18 Gresh C. CBR Scholars program. Environmental Forum

1996;l,5; no 1.

19 American Journal of Public Health. October 1996.
MULTIDISCIPLINARY 

PERSPECTIVES

Research aimed ultimately at improving 

the health of women and subpopulations 

of women across the life span focuses on 

a broad spectrum of factors. Investigations may 

examine basic, molecular, genetic, immunologic, 

and other mechanisms in the etiology and pathogenesis of disease, thus contributing to the biomedical knowledge base or to the development of

innovative therapies. At the same time, psychosocial

research seeks to improve understanding of the cultural, lifestyle, personality, cognitive, affective, motivational, social support, and other factors associated

with women’s decisions to adopt or maintain healthy

behaviors, or seek health care services. In addition,

socioeconomic research seeks to better understand 

the effects of such variables as employment status 

and income on women’s health.

Much of the research on women’s health 

conducted in the past, and even today, addresses 

questions from a specific, singular perspective rather

than from a range of biomedical, psychosocial, and

socioeconomic points of view. Research projects 

involving investigators from multiple disciplines 

are not usually the norm. However, as available

research dollars shrink, innovative integration of 

expertise from various disciplines may become 

an increasingly important strategy for maximizing

funding potential. During the past several years, 

a growing number of funding opportunities made 

available through NIH have specifically encouraged or called for multidisciplinary research teams.

Research on women’s health, because of the

encompassing nature of this area, provides a unique

opportunity to assemble researchers from multiple 

disciplines. Collaborative research projects on 

women’s health can cut across disciplinary boundaries within the basic and molecular sciences, within

medicine, and with other disciplines including, but 

not limited to, nursing, pharmacy, anthropology, 

psychology, sociology, health education, social 

work, economics, and demography. It must be 

noted that multidisciplinary research should not

replace single-discipline research but should supplement it, thereby enriching understanding and permitting the development of broad-based knowledge.

Barriers to conducting multidisciplinary 

research on women’s health issues prevail. For 

example, academic systems typically have fewer 

means of rewarding or recognizing multidisciplinary efforts. Furthermore, there are still few funding mechanisms that focus on multidisciplinary

research. In addition, researchers have limited 

firsthand experience or training in building 

and working as part of multidisciplinary teams. 

This inexperience is also sometimes reflected in 

the evaluation of study sections. Clearly, some 

changes within NIH and academic institutions 

are required if synergy between disciplines is to 

be achieved. Overarching issues and specific 

recommendations that would encourage multidisciplinary research on women’s health are 

discussed below.

Cochairs

Patricia Grady, Ph.D., R.N.

National Institute of Nursing Research

National Institutes of Health 

Brian Strom, M.D., M.P.H.

University of Pennsylvania Medical Center

Rapporteur: Susan Farer

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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

STRUCTURE OF 

NIH FUNDING 

SHOULD ENCOURAGE 

MULTIDISCIPLINARY

RESEARCH

Women’s health provides a unique, crosscutting research realm in that it is multidisciplinary 

by definition, offering important opportunities for

simultaneous study of biomedical, psychosocial, 

and socioeconomic variables. While opportunities 

for multidisciplinary research with NIH funding do

exist and are expanding, further progress in this area

should be encouraged. In addition, coordination

among the NIH institutes, centers, and divisions 

(ICDs) should be heightened in support of multidisciplinary research activities, and NIH communication about these opportunities should be enhanced.

The following recommendations are proposed in 

support of these goals.

Identify Multi-institute Issues

Issues that cut across research disciplines 

and across the missions of the NIH ICDs should 

be identified, and funding for multidisciplinary 

research should be made more readily available.

Multidisciplinary research has been developed 

for chronic fatigue syndrome with studies on searches

for a wide range of infectious agents, on different

aspects of the immune system and neuroendocrine

function and use of antidepressants to relieve 

symptoms of fatigue, sleep disturbance, and 

chronic aches and pains.

Encourage Inter- and Intra-institute 

Multidisciplinary Research

The NIH should encourage the promotion and

development of multidisciplinary research, both 

within individual ICDs and across ICDs. Program

offices within the Office of the NIH Director and 

directors of individual ICDs can play a vital role 

in stimulating cross-cutting research by promoting

research policies and funding in support of mechanisms for multidisciplinary research. The Office of

Research on Women’s Health (ORWH), the Office 

of Research on Minority Health, and the Office of

Behavioral and Social Sciences Research are already

engaged in working closely with all of the NIH ICDs 

to enhance their respective portfolios in behavioral 

and social sciences research and to identify research

opportunities that foster trans-NIH collaborations.

Use RFA and RFP Mechanisms To Support 

Multidisciplinary Research

Despite philosophical support, NIH-funded 

multidisciplinary research will not be enhanced 

unless funding mechanisms are made available 

for such research. Requests for application (RFA) 

and requests for proposals (RFP) should be developed that specifically seek multidisciplinary women’s

health-related investigations. Furthermore, the timelines for application submissions must account 

for the complexities of developing collaborations

among researchers from different backgrounds 

and perspectives.

Establish ORWH as a Broker

ORWH is in a unique position to function as a

“broker” and advocate for funding multidisciplinary

women’s health research across the NIH ICDs. This

broker/advocate role would be in keeping with the

ORWH mandate “to strengthen and enhance research

related to diseases, disorders, and conditions that 

affect women and to ensure that research conducted

and supported by NIH adequately addresses issues

regarding women’s health.” In a leadership role, 

ORWH could provide a pivotal point for communication among the ICDs regarding multidisciplinary

research on women’s health and could proactively

develop multidisciplinary research opportunities. 

In addition, ORWH could serve as a resource for 

investigators wishing to explore or develop linkages

with other investigators and research programs 

concerned with similar research topics. 
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ORWH Funding Priorities Should Explicitly 

Encourage Multidisciplinary Research

Today, ORWH vigorously implements its 

mandate to strengthen and enhance research on

women’s health, in part by providing cofunding 

to ongoing NIH grants and special initiatives that 

have gender-specific research objectives. In planning 

for the 21st century, ORWH should identify as a 

priority research that cuts across disciplines, and 

then should emphasize cofunding of investigations 

that cut across biomedical, psychosocial, and sociocultural perspectives.

Establish Multidisciplinary Coordinating Groups

Communication across the NIH ICDs and 

within the extramural research community is vital 

to increasing opportunities for multidisciplinary

research and to building multidisciplinary teams 

of investigators. Coordinating groups, committees, 

and task forces comprising program-level IC staff 

with common interests should be established to 

identify shared goals and act upon priority women’s

health research areas. For example, the Coordinating

Committee on Research on Women’s Health, coordinated by ORWH, brings together representatives 

of the NIH ICs to discuss directions for research 

on women’s health and to provide direction to the

ORWH director. Similar groups could be established 

to discuss multidisciplinary research addressing 

specific disease topics that affect women, such as

HIV/AIDS, autoimmune diseases, or heart disease.

Other examples of multidisciplinary groups 

are both a PHS and an NIH coordinating committee 

for chronic fatigue syndrome (CFS). Currently CFS 

has no definition that can be measured by objective 

criteria. Epidemiological research can help guide

hypothesis generation and testing. Research needs 

to examine prospectively the long-term prognosis 

of CFS, the patterns of disease, its prognosis in 

adolescents and children as well as in adults, and 

the cause — all of which will help lead to better 

methods of diagnosis, treatment, and prevention. 

Careful blinded therapeutic trials are also needed. 

Convene Multidisciplinary Conferences

Conferences, workshops, and symposia 

should be convened to discuss research topics on

women’s health from multidisciplinary perspectives.

Such meetings are important in examining current

knowledge, as well as theoretical and methodological

issues. The Women’s Health Seminar Series, sponsored

annually by ORWH, serves as a model for such conferences, with topics addressing such issues as genetic

testing, hormone replacement therapy, breast cancer,

and domestic violence. The series is planned and

implemented in conjunction with the NIH Coordinating Committee on Research on Women’s Health, 

ensuring that numerous perspectives are addressed.

Create Core Centers

The funding of “core centers” for research on

women’s health could be a method to encourage close

cooperation, communication, and collaboration among

investigators with similar interests who are conducting

individual research projects. The core center serves as

an identifiable organizational focal point within a single

university medical center or among a consortium of

cooperating institutions. This concept fosters interdisciplinary cooperation and the sharing of resources,

such as instrumentation or assays, thus enabling more

efficient and productive work. Core centers for research

on women’s health would not supplant investigator

capabilities but would enhance investigators’ opportunities to learn and advance. Core centers may also 

provide funding for seminars, visiting scientists, or

other program-enrichment activities.

MULTIDISCIPLINARY

RESEARCH SHOULD 

BE REWARDED 

WITHIN ACADEMIC

INSTITUTIONS

NIH and academic institutions should collaborate

to increase the amount of multidisciplinary research

conducted on women’s health issues. Institutions

should provide both philosophical support and

advancement opportunities for those who build 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

bridges across biomedical, psychosocial, and socioeconomic research domains. In addition, academic

structure should follow, not dictate, research needs.

Matrices that match the multidisciplinary interests 

and expertise of individual faculty members provide

one model for encouraging cross-cutting research 

within academic institutions. The following recommendations may assist institutions and faculty 

members in shifting toward a new way of thinking.

Encourage Promotion Criteria that Stimulate 

Multidisciplinary Research

Professional advancement in academic settings today generally hinges on success in one’s 

discipline. However, especially as federal research

resources constrict, the academic environment 

should not discourage but should reward faculty 

investigators who seek out and develop multidisciplinary research programs. Promotion criteria 

should incorporate faculty members’ initiative and 

success in this regard.

Encourage Scientists To Learn How To “Package”

Multidisciplinary Careers

If efforts related to research on women’s health 

are to be successful, investigators need to increase 

their willingness to cross academic and disciplinary

boundaries. Individual investigators need to learn 

to channel their research to fit current models and

should draw on their multidisciplinary research 

abilities in developing their careers.

Encourage NIH-funding Mechanisms that 

Support Multidisciplinary Research and 

Training at Academic Institutions

Academic institutions are more likely to 

encourage multidisciplinary research on women’s

health if NIH supports such research. Therefore, 

NIH-funding mechanisms should encourage multidisciplinary research and investigator training. 

Furthermore, NIH training and career development

grants should also emphasize the importance of 

applications proposing multidisciplinary work.

TRAINING SHOULD BE

MULTIDISCIPLINARY,

AND RESEARCHERS 

NEED TRAINING IN

MULTIDISCIPLINARY

RESEARCH

The environment in which researchers are 

trained is a critical influence and often determines 

professional directions and interests. In the past, 

students of medicine, nursing, and other professional disciplines participated in core courses 

together, providing opportunities to share ideas 

and develop an awareness of varied perspectives.

Today, the academic environment may often segregate the disciplines, thereby creating barriers to the

cross-pollination of ideas. In addition, NIH research

training and career development programs tend to 

be discipline-specific and organ-specific. Training

mechanisms, some believe, are equal to or more 

important than funding mechanisms in determining

the amount of multidisciplinary research conducted.

The following steps are recommended to enhance 

integration of disciplines during crucial training years,

as well as during the course of the research career.

Establish Multidisciplinary Training Programs

First, professional training programs that 

require or encourage cross-disciplinary study 

should be established or reestablished. Such programs would shift the learning process away from 

professional separatism and toward broad-based 

learning. Cross-disciplinary study would encourage

students to consider the spectrum of biomedical, 

psychosocial, and socioeconomic concerns that 

may interact to affect women’s health.

Publicize Effective Individual and Institutional 

Role Models

Individuals and academic institutions that 

serve as exceptionally effective models for multidisciplinary training in the field of research on 

women’s health should be recognized and publicized. Information about model training initiatives 
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that cross disciplinary and departmental boundaries

within medicine and other disciplines should be 

disseminated widely through professional meetings,

journals, professional organization publications, the

Internet, and other print and electronic media.

Publish and Publicize the Process of Putting 

Together Multidisciplinary Teams

The process of building successful multidisciplinary teams for research on women’s health 

should be documented and disseminated to 

encourage and teach others to follow suit. Only

through the sharing of ideas about the team development process will these programs effectively 

serve as models. Information should be disseminated

widely at professional meetings, in journals and the

publications of professional organizations, on the 

Internet, and in other print and electronic media.

Recognize Mentors

Mentors play a vital role in the career development of professionals in any field. This role is 

even more crucial in the relatively new field of 

women’s health. Mentors who successfully build 

collaborative teams and are involved in multidisciplinary training and research efforts should be 

recognized and rewarded.

Encourage and Provide Funding Mechanisms 

for Continuing Education in Fields Other Than 

One’s Area of Primary Expertise

Scientists wishing to pursue research careers 

in women’s health that traverse scientific and disciplinary boundaries must possess a practical understanding of the concerns, science, and methodologies

of fields other than their own. Continuing education

provides a formal means of developing this understanding, although funding mechanisms are needed 

to encourage and support researchers who wish to

maximize their capabilities in conducting multidisciplinary research. NIH training and career development grants specifically designed for researchers 

wishing to study outside of their traditional disciplinary realms may be one mechanism to 

provide such support.

Encourage NIH Institutes To Fund Multidisciplinary Training

To maintain a cadre of well-trained investigators in research on women’s health, the NIH 

ICs should be encouraged to fund research 

training and career development efforts that go 

beyond specific disciplines. Investigators-in-training with interests in cross-cutting research should be 

considered for support through National Research 

Service Awards, whether individual or institutional,

career development awards, and fellowships.

Develop Inter-institute Review Processes and 

Funding for Training Awards

The process of reviewing and funding applications for research training and career development

often fosters single-discipline and single-organ 

system approaches. If investigators-in-training in 

the field of women’s health are to develop interests 

in multidisciplinary work, then application review 

policies and procedures should ensure review by

appropriate multidisciplinary review groups that 

are also representative of multiple NIH ICs.

MULTIDISCIPLINARY

RESEARCH PROPOSALS

ARE OFTEN REVIEWED

BY SINGLE-DISCIPLINE

INDIVIDUALS

The number of NIH-funding opportunities 

that invite or require multidisciplinary research 

has increased noticeably. However, there is also 

a belief within the research community that application review committees evaluate applications for

multidisciplinary projects from single-discipline 

perspectives and represent the review committee’s

purview. Anecdotal accounts indicate, in some

instances, a lack of understanding on the part of
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reviewers that multidisciplinary projects can truly 

represent high-quality science, especially if the 

projects are innovative and methodologically 

sound. Therefore, the NIH review committee 

structure should be examined for its ability to 

ensure that multidisciplinary research applications 

are evaluated by individuals who possess a clear 

understanding of the disciplines and concerns 

involved in multidisciplinary research projects. 

This issue may be addressed through the following recommendations.

Expand Use of Ad Hoc Reviewers on 

Standing Committees

For most applications, the initial or first 

level of review involves panels of experts established according to scientific disciplines or medical 

specialty areas. The function of these scientific peer

review groups is to evaluate the scientific merit of 

grant applications. Expanding the use of ad hoc

reviewers who represent the behavioral and social 

disciplines on these standing research review 

committees would help to ensure that high-quality,

multidisciplinary research projects on women’s 

health are evaluated appropriately.

Use Ad Hoc Review Committees

Ad hoc review committees should also be 

considered for the review of multidisciplinary grant

applications. Such committees would comprise representatives of multiple disciplines that cut across the

biomedical, behavioral, and social sciences, depending on the application topic.

Solicit Reviewers with Appropriate 

Multidisciplinary Expertise

Selection of reviewers sitting on scientific peer

review groups is based in part on their expertise, 

experience, and knowledge of specific disciplines. 

Individuals with multidisciplinary expertise should 

be identified and made known to those scientific

review administrators who determine the composition of review committees.

Inform Applicants How To Use Existing 

Review Structures

NIH grant applicants must learn as much about

the grant application and review process as possible.

Increased communication with applicants regarding 

the existing review structures could be accomplished

through the NIH Division of Research Grants home

page or by other means.

Identify and Publicize Successful Models

Research review committee structures that 

serve as successful models for the review of multidisciplinary grant applications should be identified 

and their successes publicized so that they might 

be emulated within the NIH review structure.
Selected topics in Health Impact and Health Outcomes

SELECTED TOPICS IN

HEALTH IMPACT AND

HEALTH OUTCOMES

The sections in this chapter represent 

selected topics in health impact and health

outcomes that were presented at the Philadelphia regional meeting and the Bethesda national

meeting of the Beyond Hunt Valley activities to 

update the agenda for women’s health research for 

the 21st century. The topics addressed are: Gender

Considerations in Therapeutic Advances, Clinical 

Trials and the FDA Approval Process, Communications and Outreach, and Patient Care.

GENDER 

CONSIDERATIONS 

IN THERAPEUTIC

ADVANCES

A vaccine offering protection against serious 

illness, an effective drug treatment for HIV/AIDS

patients, a diagnostic test capable of detecting a 

treatable disease at its earliest stage, and artificial 

joint replacement devices: these are examples of 

therapeutic and diagnostic advances that offer 

immeasurable benefits for the health and quality 

of life of all Americans. But as these “miracles of 

modern science” are developed and used, important

gender-related questions must be asked. Are the 

side effects of a vaccine the same for men and 

women? Do men and women react in the same 

way to new HIV/AIDS drugs? Are the therapeutic 

products that have become standard clinical care

appropriate and advisable for women? Should 

artificial joint devices be designed differently for 

male and female patients? The answers to these 

questions are the essence of this discussion because, 

in fact, many therapeutic advances are put into 

use and continue to be used without consideration 

of gender differences in response to these products.

Therapeutic products are the result of a 

lengthy process that most often begins as a new 

idea is conceived, is developed in the laboratory, 

continues through various clinical research stages,

receives approval for clinical care applications, and 

ultimately reaches the marketplace and the consumer.

The extent to which this process is powered to detect

gender-specific efficacy endpoints and safety signals

before approval and is sensitive for monitoring genderspecific safety signals after approval, has important

ramifications for women’s health. To keep consumers

safe, it is important to have in place sensitive data 

collection and analysis methods that enable the 

efficient detection of gender-specific signals not 

only of new but also of old products currently in 

the marketplace. Technologies that are gender 

neutral may not look as advantageous to women 

once the data is accessed and analyzed by gender. 

The recommendations presented in this chapter 

are intended to integrate and focus attention on

women’s health, but all segments of the population 

can benefit from these proposals.

Judy Norsigian

Boston Women’s Health Book Collective

Maria Freire, Ph.D. 

Office of Technology Transfer

National Institutes of Health

Rapporteur: Debra Powell

Mary J. Berg, Pharm.D.

University of Iowa, College of Pharmacy

Jeanne N. Ketley, Ph.D.

Center for Scientific Review

National Institutes of Health

Ruth Merkatz, Ph.D., 

Women’s Health, Pfizer, Inc.

Rapporteur: Abraham Mittelman, M.P.H.

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Concept to Marketplace

Technology transfer has been defined by 

NIH as “the process by which the fundamental 

discoveries of laboratories are brought forth into 

practical knowledge and useful products for the 

benefit of humanity.” The Federal Government, 

particularly the Public Health Service, including 

CDC, FDA, and NIH and its grantee institutions, 

plays a major role in biotechnology transfer. The 

Bayh-Dole Act of 1982 and the Federal Technology

Transfer Act of 1986 encourage greater interactions

between the Federal Government and universities,

foundations, and industry through cooperative 

research and development agreements and through 

the licensing of patented inventions developed by 

public health agencies or by researchers at universities and not-for-profit institutions funded by NIH. 

Mechanisms for determining the safety and 

effectiveness of new and old therapeutic products 

are evolving. Traditional methods based on peer 

review are being transformed by advances in information technology and data manipulation, which 

simplify the collection, access, exploration, evaluation, and understanding of the safety and efficacy 

data generated on therapeutic products. The criteria 

for such assessments are being debated. Although 

“safety and effectiveness” and “risk/benefit” are 

important, these concepts mean different things 

to different people — clinicians, manufacturers, 

staff of health care institutions, and consumers. 

Disagreements persist about what level of risk to 

the individual is acceptable. How are benefits of 

the individual weighed against benefits to society?

Advances in information technology and data 

manipulation can provide objective measurements 

for determining safety, efficacy, and risk/benefit, 

including these determinations for subpopulations 

at a high risk. Information technology can also 

provide substantial evidence of the public health 

benefits and risks of therapeutic products to 

society as a whole. 

The practical business and economic implications of new product development must be 

recognized as well. Companies traditionally have

looked at new technologies and asked how they 

could make a profit. Some companies are now 

looking at unmet needs and at populations with 

large market shares and considering how to 

respond in a profitable way. 

The commercial introduction of a new product 

or procedure, however, is not the end of the process.

After a technology has been introduced to the marketplace, continual assessment is needed to ensure that

the product remains safe and efficacious and does 

not become obsolete. Prenatal ultrasound testing is 

one example of the need for such assessment. The

National Institute of Child Health and Human Development, along with the NIH Office of Medical Applications of Research, sponsored a workshop titled 

Ultrasound Screening: Implications of RADIUS 

(Routine Antenatal Diagnostic Imaging Ultrasound

Study). RADIUS, a large, randomized clinical trial,

assessed the effectiveness of routine ultrasound 

screening for pregnant women at low risk for poor

pregnancy outcomes. Although the study results 

indicated no real medical value of ultrasound for 

this population, practitioners have continued to 

use the technology. This is an example of an adaption of a technology from an original application 

in high-risk situations to an entirely different situation, the efficacy and cost effectiveness of which 

may be questionable. Another example of a reassessment that brought about significant change 

was reducing the dosages of oral contraceptives

because of safety considerations.

The following recommendations encourage 

a more deliberate assessment of new therapeutic 

products as they affect women and call for ongoing assessments that consider women’s health 

perspectives:

• Keep consumers safe. Make gender-specific 

analysis of safety and efficacy data and 
“Outcome measures that have meaning for

women with a chronic disease (such as arthritis) must

include a measurement of functional status and an

assessment of their quality of life.”

Brenda Crabbs

Arthritis Foundation

233

VOLUME 2

identification of outliers a critical element 

prior to any transfer of new therapeutic 

products to the marketplace.

• Identify and evaluate therapeutic products that 

warrant further research based upon the ORWH 

agenda. Assess, in a systematic way, which 

therapeutic products are obsolete, not effective, used inappropriately, or warrant dosage 

reductions in women or in other subpopulations at risk.

CLINICAL TRIALS AND

FDA APPROVAL PROCESS

Clinical trials are usually undertaken as a threephase activity. Clinical research may be sponsored 

and funded by the Federal Government and by 

private industry. Participation in clinical trials is 

voluntary and offers individuals who meet the 

specific medical criteria access to promising drugs,

devices, and treatments long before they are approved

for general use. Institutional Review Boards seek to

protect participants’ rights and safety by ensuring 

minimal risk, potential benefit, appropriate recruitment strategies and thorough informed consent 

procedures. Participants should also be provided 

medical care throughout the investigation. 

As for all medical technologies, clinical trials 

are a key stage in the introduction of new therapeutic

products. Such trials raise many crucial overarching

questions. For example, how can research designs 

be modified to encourage greater involvement by

women (i.e., clinical trial participation)? How can 

we increase the statistical power to detect meaningful gender differences? Coming up with increased

statistical power to analyze the data by gender will

involve more than just including women. Current 

clinical trials are not sufficiently large or of sufficient duration, in general, to detect rare or delayed

adverse events, regardless of gender. Which populations of women are not now participating in trials?

Which populations of women cannot be analyzed 

in trials because of a lack of statistical power to 

separate their safety profile from the average 

responder? Can new kinds of trials be designed? 

What ethical and social issues are involved?

Ensuring diversity and pluralism is part of 

the challenge. The involvement of communities in

research design, implementation, and recruitment 

must be encouraged. For example, the HIV/AIDS 

and breast cancer activist communities have been 

heavily involved in the clinical trials process.

In addition to research design and implementation, questions arise about what constitutes “safe 

and efficacious” drugs, biologics and devices, and

about the necessary level of regulation. The FDA 

regulates medical devices based on their degree 

of risk to the public. Devices that are life-supporting, life-sustaining, or implanted must receive the

agency’s most stringent approval before they can 

be marketed. But what level of certainty should 

be required? What are appropriate endpoints? 

Should there be standards for performance?

Research on technology applications in the 

area of prevention also deserves greater attention. 

Traditionally, prevention has been underfunded 

relative to other categories of research. Two such 

areas that have and will continue to have a major

impact on women’s health are contraception and 

prevention of sexually transmitted diseases. However, other areas of prevention need our attention 
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as well. The analyses of clinical trial and postmarketing data present opportunities and challenges 

for identifying adverse events and deaths that are

potentially avoidable and for discovering new 

toxicities that have not been described. Many 

products are still in the marketplace that cause 

side effects that are not properly appreciated. 

Once the source of these problems is identified, 

the toxicities might be prevented. One example 

is drug-related torsades de pointes. This serious 

cardiac adverse event occurs mostly in women, 

and can be caused by overdosage with terfenadine 

or astemizole or with recommended doses of these 

and concomitant administration of other drugs 

that inhibit P-450 metabolism.

Recommendations to improve the process 

include the following:

• Reassess the adequacy of current dosage 

recommendations of approved drug products 

to optimize dosages for women.

• Improve the quality of study design, data 

collection, analysis and reanalysis of the data.

• Establish databases that include analysis of 

data by gender, hormonal status, age and race, 

and clinical outcomes.

Identification and Quantification of Risks Associated

with Use of Pharmacological Agents

Identification and quantification of risks associated with use of therapeutic agents is among the 

most pressing problems of all research priorities, 

and affects the basic quality of health care for the 

entire population. Although the scope of the problem is extremely broad and its potential solution 

difficult, many fundamental steps can be taken, 

both short and long term, to broaden our understanding of these risks. Because of the extent of 

work required, it may be necessary to pool resources 

of both public and private sectors. Within the public

sector arena, broad interagency collaboration (NIH,

FDA, AHCPR, NSF, and CDC) is crucial to develop 

and implement methodical and uniform processes 

and systems to enhance the value of clinical data,

improving the consistency and interpretation of 

collected data, and expediting adoption of important research recommendations. Industry must 

collaborate with academia in this research because

these groups sponsor and/or conduct the majority 

of pharmacological research in this country.

Current methods to detect adverse events 

include reviews of case series, qualitative summaries 

of safety data from clinical trials, voluntary reports, 

and epidemiologic studies of suspected agents. Scientific research is needed for developing improved 

methods to monitor, identify, and quantify hazards

associated with use of pharmacologic agents. More 

sensitive methods are needed to identify high-risk 

subgroups (e.g., variations in risk by gender, age, 

race, concomitant medical conditions) as well 

as drug-drug and drug-nutrient interactions.

Limitations of Clinical Trials

Drugs, biologics, and devices that are tested 

for safety and efficacy in clinical trials are generally

administered only to a small number of people 

before being released into the general population. 

Even large trials, however, may be too small to 

pick up rare side effects. A great deal can be learned

about a product after it is approved and released in 

the marketplace. In the general population, discovery

of adverse events caused by therapeutic agents is 

difficult unless a large number of people are affected,

or if the adverse event is very unusual.1 Discovery 

of adverse events may take years. Factors that increase

the difficulty in recognizing adverse events include 

the degree to which clinicians are adequately trained 

or prepared to recognize signal (“red flag”) cases, the

extent to which clinical and pharmacologic factors

responsible for adverse events are understood, the

degree of knowledge of risk factors for individual 

susceptibility, and the presence of many confounding factors that may obscure identification of toxic 

drug effects,2-4 and the quality of the processes 

of data collection and cleaning.
“A society of active individuals begets a healthy

nation, which can recognize real savings in health 

care costs through the fitness of its citizens.”

Mary Lloyd Ireland, J.D.

Ruth Jackson Orthopaedic 

Society

235

VOLUME 2

Clinical trials may have sufficient statistical 

power to detect differences in primary efficacy 

endpoints but not enough power to detect rare 

or delayed adverse events.5,7,8 Thus, an adverse 

event that shows up once per thousand persons 

may not appear at all in a trial of only several 

hundred people. Additionally, estimates of measures 

of central tendency are inappropriate for identifying

uncommon responders. The safe use of a drug or 

biologic agent may be determined by multiple and

complex interdependent factors. These factors 

include pharmacokinetics; pharmacodynamics; 

drug dose; adaptation; demographic characteristics such as gender, weight, age, and race; 

immune response; and concomitant conditions 

or medications.

Lack of Standardized Data Structures

The lack of uniformed standardized data 

structures is a critical and almost uniformly ignored

problem and presents a major impediment in the 

ability to accurately access and interpret vital data 

in basic and applied clinical research. This problem, which applies to clinical data collected during

clinical trials, as well as from medical claims databases, longitudinal electronic medical record 

databases, hospitals, and HMOs, unnecessarily 

complicates retrieval of information.6-8

There is a pressing need to standardize databases to enable analysis, comparison, and merging 

of data. Prescribers rely on clinical trials as the 

major source of information on which to base 

medical decisions, yet tremendous amounts of 

information in clinical trials remain untapped, 

including information critical for women’s health. 

In clinical trials, for example, data are often derived

from multiple, independent research groups (e.g.,

groups and separate projects within a pharmaceutical company; contract research organizations; 

academic institutions; and government agencies, 

such as NIH), each of which designs studies and 

collects and processes information independently. 

The processes of these stand-alone systems are often

not consistent from project to project or group to

group. Thus, it is difficult, if not impossible, either 

to compare results or to merge data sets in order to

increase statistical power. Examples of inconsistencies

that hinder the data merging process include using 

different variable names for the same parameters, 

different names for the same drug, different formats 

for data values (even for dates), and several units of

measurement for the same analytes.6 As a result of

these differences, clinical trial data require extensive

“cleaning” before such data can be extracted for analysis.11 This lack of standardization also means that the 

software programming generated to review one study

often cannot be applied to the next study, or to the

next project, and that collected data are not readily

available for analysis. To date, uniform standards for

collection, representation, and organization of clinical

safety information have not been developed.

Voluntary Reports of Adverse Events

Currently, FDA uses a system called the 

Adverse Event Reporting System (AERS), which 

is based on reports received from health care providers. The primary purpose of AERS is to provide 

signals of the existence of serious, unexpected 

adverse events and to aid in the further assessment 

of associated risk factors. The voluntary nature of 

such reports tends to result in under-reporting and

underestimating the actual frequency of occurrence 
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of adverse events. In one study, for example, it was

demonstrated that the reported rate of an adverse 

event was 300 times higher when prescribers were

asked if they had observed a specific adverse event.12

Another complication factor is that serious omissions

often occur in these spontaneous reports, such as 

missing data on gender and race, on daily dose, 

form and duration of the reported drug, on concomitantly used drugs (thus making it difficult to

assess drug-drug interactions), and on concomitant

medical conditions. As new drugs, new drug combinations, and untested dietary supplements enter 

clinical use there is always the possibility that new

adverse effects will go unrecognized.

A recent meta-analysis to estimate the incidence of serious adverse drug reactions (requiring 

hospitalization, permanently disabling or fatal) in 

hospitalized patients suggests that the problem of

adverse drug reactions (ADRs) may be more urgent

than previously thought.13 Researchers examined 

four electronic databases and found the overall 

incidence of ADRs to be extremely high, with serious

reactions affecting nearly 7 percent of hospitalized

patients. Their findings point to the possibility that

fatal ADRs could be between the fourth and sixth 

leading cause of death. Additionally, on the basis 

of several studies reporting an increased incidence 

of ADRs among females, these researchers suggested

that women could be at greater risk than men. The 

authors noted that, although their results “must 

be viewed with circumspection because of heterogeneity among studies and small biases in the 

samples, these data nevertheless suggest that 

adverse drug reactions represent an important 

clinical issue.”

Recommendations for clinical trials follow:

• Develop improved and more sensitive systems 

for collecting and analyzing adverse events by 

gender, age, hormonal status, and race.

• Organize a multidisciplinary “think tank” that

includes the NSF (an agency experienced in 

analyzing large databases in real-time, such 

as the visualization of the Mars landing).

• Identify all elements essential for a complete comprehensive data structure. Develop one common

language, such as a medical informatics system, 

to be used in all forms of clinical record keeping

and reporting from clinical trials, hospitals, HMOs,

Medicaid and Medicare databases, case-control 

studies, large longitudinal databases, and systems

for collecting adverse events. This effort should

include standardized nomenclature for therapeutic

agents. As part of developing such a system, various cost incentives for implementation need to be

considered. In order to collect and study clinical

outcomes in subpopulations, the common language would have to be sensitive to gender, age, 

weight, menopausal status, use of hormones, 

and race and ethnicity.

Research Goals

• It is strongly recommended that a common 

standardized database structure for clinical 

trial data from research to clinical practice 

be developed and implemented throughout 

the health care system to improve the quality 

of data and to simplify timely data retrieval 

and signal generation analysis. This could 

also extend the capability of searching across 

studies and across drugs for information 

required to understand drug safety issues 

in women. For example, such a common 

structure would allow rapid access to safety 

information related to concomitant use of 

hormonal replacement therapy with other 

medications and be used for efficient identification of previously undetected safety 

signals and for identification of dose 

reduction needs.
“Perhaps if we changed our conceptual 

framework to one of “caring” rather than one 

of “curing” we could all expect a better death.”

Janet Heald Forlini, J.D.

The Center to Improve 

Care of the Dying, and 

Institute of Medicine

237

VOLUME 2

A potential starting point might be standardization of nomenclature of diagnostic entities. 

Starting with one discipline, such as obstetrics, 

and a small number of clinical entities, such as 

hypertensive disorders and labor abnormalities, 

a consensus process could be developed. This 

process could be based on existing consensus 

groundwork created under the International 

Conference for Harmonization of Drug 

Development (ICH). Because listing all terms 

will be difficult, techniques/systems capable 

of text searching need to be developed.

• Develop strategies to improve the quality of 

reporting adverse events. Determine the best

way(s) to improve the acquisition of adverse 

events reports after use of pharmacologic and 

biologic agents and devices in the general population. Determine how the reporting of serious

adverse events can be increased on the part of individuals from the pharmaceutical industry, HMOs,

pharmacies, and physician practices. 

Most important, develop effective implementation strategies to achieve these objectives.

• Develop population-based record linkage 

systems that can be used to assess the incidences of adverse drug reactions, compare 

and evaluate risk factors, and assess the 

changing prescribing patterns among health 

care providers functioning either independently 

or within managed care organizations.

• Develop systems for analyzing large amounts 

of data in order to detect differences by gender, 

age, and race in rates of serious adverse events

caused by therapeutic agents used either alone 

or in combination. This includes identifying 

(a) subpopulations of women who may be at 

a higher risk of developing serious adverse 

events and (b) the complex web of drug interactions that may lead to serious adverse events 

in women, including the influence of exogenous

sex hormones. It may be helpful to consult with

other agencies that process massive amounts of

data, such as those involved with the space programs (e.g., NASA, NSF) to determine if their 

data collection and processing technologies 

can be transferred and adapted to this part 

of the health care sector.

• Develop tools that will systematically screen 

and analyze available databases during the postmarketing period (after a drug is approved for 

use) for identification of “higher than expected”

risks associated with the drug combinations.

• Develop data mining techniques that are capable 

of detecting patterns of associations in large databases to systematically screen these databases 

for the presence of gender-specific adverse 

events and for drug interactions.

• Consider a new system/entity for postmarketing surveillance that will (a) foster cooperation

among existing postmarketing surveillance 

programs, (b) develop new methods for carrying out surveillance, and (c) train scientists in 

the disciplines needed for doing safety analysis 

of clinical trial data for performing postmarketing surveillance.

• Cause of death rankings accounting for ADRs 

in hospital patients should be assessed with 

a gender component.
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• Implement prospective methods for collecting 

data on drug use in pregnancy. Measure outcomes such as spontaneous abortion and 

followup of live births at different time points. This

could be done through establishment of 

a prospective birth registry at academic centers 

or through funding of other organizations 

interested in developmental toxicology, such 

as the Organization of Teratology Information 

Services. To successfully accomplish this, it 

is very important to develop a method for 

linking mothers and their infants’ data records.

• Conduct research to assess potential adverse 

effects on mother and fetus of dietary supplements

taken most frequently by pregnant women.

COMMUNICATION 

AND OUTREACH

On matters pertaining to therapeutic and 

diagnostic advances, communication and outreach 

to health care providers, health professionals, and 

the public remains an enormous challenge. What 

are the best ways to disseminate objective information on therapeutic advances after they reach the 

marketplace? How can practitioners keep informed 

and current on the range and volume of developments in therapeutic advances as well as changes 

in the standards of care? In addition, translation 

of technical information into lay terms must accommodate the needs of different audiences. The role 

of the media in this process is also a factor. How 

do you create responsible media?

Identifying mechanisms by which new 

therapeutic advances may be integrated into the 

education process for practitioners is critical. For 

example, how can state-of-the-science information 

on such complex and dynamic topics as genetics 

be incorporated into medical school instruction? 

Epidemiologic and biostatistical training and 

education also are lacking despite the fact that 

these skills are fundamental to medical, nursing, 

and other disciplines. 

Seeking input from the populations affected 

by a disease on their most pressing needs should 

be an ongoing process. How can we ensure that 

the interests of those outside the scientific and 

business worlds are taken into consideration and

served? For example, the HIV/AIDS and breast 

cancer advocates represent a new level of involvement by nonscientific communities. How can 

meaningful forums be developed for the exchange 

of information between and among scientists, 

practitioners, and consumers?

On a related topic, an important part of communication is listening. Every clinician knows the

value of listening to patients to obtain useful histories. It is equally compelling for clinicians to hear

their patients’ reports of problems with drugs. Women

trying to report side effects are frequently dismissed. 

It is important for clinicians to listen to reports of

adverse events from both men and women and to

respond appropriately to these signals.

Recommendations to improve these channels 

of communication are as follows:

• Establish Internet outreach to consumers 

and health care professionals on up-to-date 

safety information, including labeling changes.

Link commercial company advertisements to 

this web site.

• Network with private and academic institutions such as Poison Control Centers and 

Schools of Pharmacy and Medicine to gather

adverse event data efficiently.

• Continue to sponsor dialogs among clinicians, 

scientists, advocacy groups, managed care

providers, insurers, and other parties to improve

overall communication on such topics as concepts of safety and efficacy, concepts of risk 

and benefit, and consequences for both the 

individual and society.
“. . . based on current research, it appears 

that relative to men, smoking behavior of women 

is reinforced less by nicotine intake and more by 

other, non-nicotine factors. If confirmed, these 

sex differences would have important clinical 

implications; nicotine replacement may warrant 

a less important role in smoking cessation while 

interventions to counter non-nicotine aspects of 

smoking may need to be emphasized.”

Kenneth A. Perkins, Ph.D.

University of Pittsburgh 

School of Medicine

239

VOLUME 2

• Continue to seek input from diverse populations of women regarding their most pressing

health needs and concerns to ensure their 

inclusion in the research agenda.

• Work with health educators to integrate 

gender-based science into the curriculum.

• Provide patent extension when a firm 

improves the safety profile of the drug.

• Determine the best way to inform both health 

care providers and consumers about risks and 

side effects.

Education of Health Care Providers about 

Pharmacologic Agents

Scientific advances have enhanced our 

ability to understand how gender-specific factors 

influence the action of drugs and modulate their 

effective use as pharmacologic agents. However, 

there is a lag between basic scientific research and 

its application in the health care setting. Training 

and education programs are needed to ensure that 

pertinent research results are properly disseminated

and integrated into health care practice.

It is important to emphasize that more coursework in pharmacology is not needed, but rather 

an integration of clinical experience for dentistry, 

medical, nursing, and pharmacy students. Many 

health science centers have clinical rotations that 

combine some or all of these students. These rotations optimize the knowledge from each discipline 

and teach the students a team approach to health 

care that they take with them into their practices 

or research. 

Optimal drug therapy; counseling patients; 

monitoring response to therapy; anticipating and

reporting adverse drug reactions; and understanding

individual variations due to race, age, gender, drugdrug interactions, potential drug-food interactions, 

and drug-dietary supplement interactions are 

components of education important to all health 

care professional students, including dentists, physicians, pharmacists, physician assistants, and nutritionists. Ideally, education will include interdisciplinary

components that foster cooperation among the 

health care disciplines and further promote the 

best interests of patients.

Additional education regarding the proper 

prescribing of medications is needed for nurse 

practitioners, physician assistants, and pharmacists. 

In addition to their varying levels of prescriptive

authority (nurse practitioners and physician assistants have prescriptive authority in 49 states; pharmacists have prescriptive authority in 18 states) 

these health care providers spend considerable time

talking to patients regarding their medications and 

are often the first to observe or hear about adverse

events that may be due to such medications. It is 

also important to recognize that in areas where 

there are shortages of primary care physicians and 

in poverty areas, nurse practitioners and physician

assistants may deliver the bulk of care.
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Recommendations

• Develop improved training and education 

programs for health care providers.

Research Goals

• For optimal health care of the patient, it is 

essential that the following organizations work

together to teach health care students optimal 

safe and effective use of pharmacologic agents:

American Association of Colleges of Pharmacy,

American Association of Medical Colleges, 

National League for Nursing, and American 

Association of Dentistry Colleges. 

• Increase continuing education activities and 

requirements for practicing health care providers to update their knowledge about 

pharmacologic and biologic agents including: new indications for marketed products, 

adverse drug reactions, inappropriate or 

ineffective uses for established products, new

approved products, and products withdrawn.

P A TIENT CARE

The cost-effectiveness of treatment is an 

essential part of consideration in clinical care, 

particularly in the managed care environment. 

But the question remains: When are technologies

advanced enough to gain status for third-party 

reimbursement? Even in a climate of cost-containment, physicians in managed care, specialists, 

and primary care physicians must be held to 

certain standards of care. Improvements in the 

education of health care practitioners and in 

changes in clinical care practices are essential. 

In addition, the insurance industry and the 

Health Care Financing Administration should 

be included in the education process that addresses

new and emerging applications of biotechnology. 

The issues are (a) to pay for care that demonstrates

effectiveness or (b) not to pay for care when effectiveness is not demonstrated or the impact on clinical 

outcomes is negligible.

Clinical practice guidelines, which recommend

appropriate practices based on existing scientific 

peer reviewed literature and clinical experience, 

should incorporate gender as a variable. There is 

need to define quality and outcome measures that 

are broader and more sensitive to women’s needs 

and better measures of quality of care. To illustrate, 

a manufacturer of a hip replacement device refused 

to make a device that would be compatible with the

female anatomy despite problems that women were

experiencing with the hip replacement device because

of its large size. The issue is not just developing new

technologies, but also refining technologies and practices from a gender perspective, particularly in managed care settings.

The NIH Consensus Development Program 

is a significant health technology assessment and 

transfer program. A consensus statement evaluates

state-of-the-art scientific information on a given 

biomedical technology with the purpose of resolving a particular controversial issue in clinical 

practice. Statements answer a series of questions 

concerning efficacy, risk, and clinical applications 

and recommend future use. However, the effect 

of the Consensus Development Program on clinical

practice is unclear, since there are various nonmedical factors involved. The program has, 

however, had measured success in influencing 

reimbursement policy and specialty organization 

policy, thereby indirectly affecting physician 

behavior. The Consensus Development Program offers one avenue for implementing 

the following recommendations:

• Involve a broad constituency in developing 

professional practice guidelines that have 

gender-specific components.
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• Identify quality and outcome measures 

that are broader and more sensitive to 

women’s diverse needs.

• Propose improvements to existing technologies and standards of care based on new 

information on gender differences.

Gender Effects on Drug Compliance 

and Drug Access

Upon diagnosis of cardiovascular disease, 

women, particularly black women, have a worse 

prognosis than do men.14,15 One of the factors 

predisposing women to adverse outcomes is older 

age of onset. Although many of the traditional risk

reduction therapies are equally successful in men 

and women,16,17 other nonphysiological factors 

such as compliance with therapeutic regimens 

and access to care may play a role in prognosis 

for women.

For HIV, where adherence to prescribed 

therapies is particularly important, the available 

literature suggests that gender does not predict 

adherence. Factors that predict access to therapy 

may differ considerably from factors that predict 

adherence, and both may vary by disease. Research 

is needed into factors that may be barriers to appropriate care among women, including physicianprescribing behaviors, ability to pay, education, 

age, medical condition, functional limitations, 

and social support.

Recommendation

• Clarify effect of gender on compliance and access.

Research Goals

• Establish whether gender is a significant factor 

in compliance and, if not, identify other factors

useful as predictors of compliance for women.

• Determine if gender is a factor in successful 

access to therapeutic agents, and if so, ascertain

causes of this phenomenon.

• Investigate factors that may present barriers to

appropriate care among women, including ability

to pay for medications, educational level, health

literacy, age, concomitant medications and conditions, functional limitations, and social support. 

References

1 Szarfman M, Chen MD, Blum C, et al. More on 

fluoroquinolone antibiotics and tendon rupture. 

N Engl J Med 1995;332:193. (Correspondence)

2 Peck CC, Temple R, Collins JM. Understanding 

consequences of concurrent therapies. (editorial, 

comment) JAMA 1993;269;1550-2.

3 Honig PK, Wortham DC, Zamani K, et al. Terfenadine-ketoconazole interaction. Pharmacokinetic 

and electrocardiographic consequences. JAMA

1993;269:1513-8.

4 Woosley RL, Chen Y, Freiman JP, Gillis RA. Mechanism of the cardiotoxic actions of terfenadine. JAMA

1993;269:1532-6.

5 O’Neill R. Assessment of safety. In: Peace KE, ed. 

Biopharmaceutical statistics for drug development. 

New York, Basel: Marcel Dekker, 1998.

6 Szarfman A. Improving the system needed to handle 

clinical trial data. Reg Aff Focus 1996;1(5):12. 

7 Levine JG, Szarfman A. Standardized data structures and visualization tools: a way to accelerate 

the regulatory review of the integrated summary 

of safety of new drug applications. Biopharm Rep

1996;4(3):12-7.

8 Szarfman A, Talarico L, Levine JG. Analysis and risk 

assessment of hematological data from clinical trials. 

Toxicology of the hematopoietic system. In: Sipes IG,

McQueen CA, Gandolfi AJ, eds. Comprehensive 

Toxicology 4. Elsevier Science, Inc., 1997, p. 363-79. 

9 Report on the IAI workshop on ENSO and interannual 

climate variability (July 12-15, 1994; Lima, Peru). IAI

Newsletter. August 8, 1995.

10 Report of the IAI workshop on the study of the impacts 

of climate change on biodiversity (Aug. 9-12, 1994;

Guadalajara, Mexico). IAI Newsletter. August 8, 1995.
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11 Bennet ST, Adams JA. Measuring the clinical development process. Appl Clin Trials 1995;4:44.

12 17th French Pharmacovigilance Meeting. Prescrire 

International 1996;5:86.

13 Lazarou J, Pomeranz BH, Corey PN. Incidence of 

adverse drug reactions in hospitalized patients. JAMA

1998;279:1200-05.

14 Kannel WB, Wilson PW. Risk factors that attenuate 

the female coronary disease advantage. Arch Intern 

Med 1995;155:57-61.

15 Tofler GH, Stone PH, Muller JE, et al., and the MILIS

Study Group. Effects of gender and race on prognosis 

after myocardial infarction: adverse prognosis for 

women, particularly black women. J Am Coll Cardiol

1987;9:473-82.

16 Collins R, Peto R, MacMahon S, et al. Blood pressure,

stroke, and coronary heart disease. 2. Short-term 

reductions in blood pressure: overview of randomized

drug trials in their epidemiological context. Lancet

1990;335:827-38.

17 Gueyffier F, Boutitie F, Boissel JP, et al. Effect of 

antihypertensive drug treatment on cardiovascular 

outcomes in women and men. A meta-analysis of 

individual patient data from randomized, controlled 

trials. Ann Intern Med 1997;126:761-7.
presentations at bethesda national meeting

REMARKS Barbara A. Mikulski, M.S.W., Senator, U.S. Senate

My heart is filled with joy because of knowing how all of this got started. On that dramatic day, September 10, 1990, Congresswomen Connie Morella, Pat Schroeder, and I showed up on the steps at NIH to launch what we hoped was going to be a women’s health initiative. We then went to the conference

at Hunt Valley, and we now are at this convocation to decide what is the future research agenda for moving ahead

in the women’s health initiative.

When I was in the U.S. House of Representatives, the Congresswomen embarked upon a women’s health equity

act, and we wanted to increase funding at NIH and make sure that the gender-specific diseases were taken seriously.

We had a variety of GAO reports that showed that women had been systematically excluded from protocols, but 

no matter what our exhortations were, we could not bring about the change that we wanted. So I, then as the U.S.

Senator, with Senator Kassebaum, called our colleagues in the House and said I think it is time we do something.

We have to get all the directors of NIH institutes around the table and ask them what are their goals and timetables

for including women in research. 

When Bernadine Healy was appointed as the Director of NIH, we considered that an enormous breakthrough.

However, a new director, without a firm, clear policy and a legislative initiative could be a hollow opportunity. We

went in and had our conference, and we talked with all of the institutes because in addition to breast cancer, ovarian

cancer, issues related to pregnancy, reproduction, things specific to being a woman, we also knew that every illness

has a gender impact, whether it is heart disease, lung disease, lung cancer, Alzheimer disease, alcoholism, or other

substance abuse. They all had gender differences or gender distinctions. We wanted to be sure that these issues

were included in the research plan of the National Institutes of Health.

We came back to Congress and introduced legislation. I took the lead in the Senate to establish the Office of

Research on Women’s Health and then also moved forward with adequate funding. Dr. Healy was sworn in through

a very prompt appointment process. She appointed Dr. Vivian Pinn the Director of the Office of Research on

Women’s Health, and we convened the agenda. I believe the momentum has been growing ever since. All of 

you are in this room because you want to show that sound science should be able to save lives. 

I want to congratulate you. Whatever your fields of endeavor, whether you come from clinical practice, whether

you come from a basic research area, whether it might be applied research in medical devices or better diagnostic

tools, whether you are in epidemiology, whether you are looking for the genes, or you are looking for another

answer, I want to say thank you because what we did was to create a framework to unleash the creative capacity 

of the scientific community to focus on the women of this country and, therefore, on the families of this country. 

I just want to say thank you for taking the dream to a reality and having that reality based on sound science.

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Let me say that one of my proudest moments, in addition to helping establish the Office of Research on

Women’s Health, was to be a leader in the United States Congress to keep the women’s health agenda a nonpartisan agenda item so that we would never, ever play politics with it. When the new women came to the 

Congress and the Senate in 1992, I organized the Democratic women and worked with Senator Kassebaum. 

Then, shortly after we were joined by Senators Kay Bailey Hutchinson, Olympia Snowe, and Sue Collins. We 

hope by the year 2000, we will be nine and beyond, so we have a league of our own and not be a little league 

in the U.S. Senate.

We meet once a month, and we talk about our lives and our times, and we strategize. We vowed that we would 

not make the women’s health agenda a Democratic or a Republican issue. We would make it an American issue,

and that is what we have done.

I was so proud when we worked to move the reauthorization of the mammogram quality standards. We 

wanted to make sure that mammograms were safe for the women who got them, safe for the people who gave

them, and people were trained on adequate equipment. We, the women of the Senate, sent out a historic letter 

that said, “We, all of the women of this Senate, invite all of the men of the Senate to join with us in the reauthorization of the mammogram quality standards.” 

Within 72 hours, we had 53 cosponsors on both sides of the aisle, and that law has now been reauthorized 

on a voice vote. That is what being non-partisan is all about. So whether it is working on the women’s health agenda,

whether it is working on FDA reform to streamline the regulatory process to make it safe and effective, and also 

to be sure that NIH and its extramural programs have adequate funding, we are there working and fighting.

In conclusion, let me give you some reminders. One is do your research. I want us to be sure that we look 

at new ideas and new opportunities. The women’s health initiative was never meant to be a new revenue stream 

for old ideas. We need you to speak up. I want to see women scientists advance because often, although we have

new ideas, old cultures continue to persist in the scientific community. We want to fund those young investigators

who also might even be iconoclastic, open to new ideas, new modalities, and, I believe, some new profiles of 

who does the research in this country. 

Second, I would encourage us not to look for silver bullet solutions. I know that Dr. Francis Collins will 

be speaking about the wonderful work that is now going on in gene research, but let us not only focus on the 

fact that if we find the right gene at the right time, that is going to be the only solution. Each and every one 

of you knows we need to look at broad-based research, that there will not be any one answer, not only one 

cure, and not only one solution.

The third thing that I would encourage is that we also do more research into behavior. We know that some of 

the greatest causes of those issues affecting women, particularly heart disease and lung cancer, are behavior-based.

But there seems to be very skimpy research. Often we hear about diet. Behavior-based research is about nutrition

and exercise, and yet, it is very hard to get that type of information. We know that when women have a heart

attack it is often treated differently. Men go into acute care, and if they are tycoons even find whole new low-fat

products. We women are often in Weight Watchers and many of the other programs, by the way, which might 

even be more effective than some of the other programs, but we often are not treated the same. 

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We see our problems as obesity. They see their problems as medical ones. We get all tied up with all kinds 

of other issues in our mind, in our heart, and in our body. We need to have a look at behavior and how we can

enhance our health and well being.

We also need to look at the behavior of doctors and how we can take some of the new ideas and the research

and move it to clinical practice. Many physicians do not recommend that their patients get mammograms. Many 

of them still continue some of the old stereotypes and practices, and when it comes to other issues like heart 

disease and obesity, we know that the failure of phenfen was not a failure of FDA approval; it was the failure 

of the right advice being given in the right way to patients. 

Last, we need to look at caregiving. Right now people are worn out, and they are worn down because of the

whole issue of three shifts, one in the marketplace, one in the family and then one often in the community. Taking

care of your children is child care and then taking care of your mom and dad is eldercare. We need to focus on

caregiving. What does it take to do that? What does it take to support that and then how we can move ahead 

to be able to do it. These, I believe, are some of the new frontiers of research and how we need to move ahead.

The other thing that I am going to encourage you to do is come out of your labs and fight. Help join with 

the women of the Senate, the women of the House, and the galas that support us for more resources, for more

resources in research for you to be able to do your outstanding work. 

I also ask you to come out of your laboratory to fight against the excesses of managed care. We need to bring

health disciplines to our health care system, but managed care was never meant to be manacle care. Managed care 

is systematically believing that it is moving away from a research agenda so that we could have those new ideas

that lead to new improvements in clinical practice. Right now, those of us in Congress know that we need to have 

a framework of managed care: the solvency of Medicare, the reliability of Medicaid, and the other issues related 

to access of health care.

What I am concerned about is the lack of quality standards. The fastest growing number of constituent complaints in my office are about not knowing what their health care plans cover and whether they will have the health

care that they need. I am not opposed to managed care, but I am certainly opposed to its excess. So I will be part 

of a coalition in Congress talking about quality standards in managed care and for a consumer bill of rights so 

that you do have access to what you need. 

Olympia Snowe, Connie Morella, Nancy Palowsi, we do not want to be fighting this one organ at a time. 

We really don’t. We want to have an organized systematic way that respects us, respects our lives, and fundamentally makes the decisions about patient care in the consulting room and not in the board room. 

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REMARKS Constance A. Morella, M.A., Representative, U.S. House of Representatives

I

t is an honor to be here with all of these dedicated people. You are preparing your health research agenda 

for the 21st century, which is going to be very critical in the development of our agenda for women’s health 

as we go into the new century. 

Women’s health issues are a high priority of the Congressional Caucus for Women’s Issues and also for a number

of male members as well. They very often look to us, as women, for the lead, but then they do follow and become

advocates too. We are going to look forward to the report that is going to come out of this conference to help us

develop our public policy priorities for the next century.

The Women’s Caucus emanated in 1989 from a GAO report, which indicated that not much was happening

with regard to women. I recall this vividly whenever I see Bill Raub, because he was the one who announced that

there would be an Office of Research on Women’s Health. We had legislation on women’s health equity that was

submitted and codified, and you know that the Revitalization Act of NIH contains the requirement that women 

be included in all clinical trials and protocols unless there is a good reason not to do it. 

Since 1990, we have made great progress in the funding for women’s health centers; the concerns of breast,

ovarian, and cervical cancer; study of osteoporosis; and establishment of the Women’s Health Initiative. For example, breast and ovarian cancer funding at NCI has more than quadrupled since 1990. Funding for osteoporosis 

has grown from only two osteoporosis-specific grants in the entire country in the early 1980s to $80 million 

in osteoporosis-specific research grants today.

However, I submit our job is far from over. Despite great strides in women’s health research, we still must 

be vigilant and must address some issues that are not receiving the public attention and research priority that 

they deserve, and those are some of the issues that I thought I would mention.

For example, HIV/AIDS is the fourth leading cause of death in young women, and the number one cause of

death for young African-American women. Sexually transmitted diseases, including HIV, continue to ravage our

country. Each year 12 million new STD cases are reported in the United States. Twenty-five percent of that number

are in teens, which translates into a rate of one in eight teens who are infected with an STD. And these figures only

represent the reported cases. Health experts believe that about one in four sexually active teens becomes infected.

Adolescents and minorities are most severely affected by STDs. The highest rates of chlamydia and gonorrhea

among women occur in 15 to 19 year olds. Incredibly, the gonorrhea rates in this country approximate those in 

the developing world. The consequences of STDs are most severe for young women because there are often few, 

if any, symptoms. STDs, therefore, may go untreated leading to potentially serious conditions, including ectopic

pregnancy, infertility, chronic pain, and poor pregnancy outcomes. In fact, the group most likely to die from

ectopic pregnancies are African-American teens. 

Infection with the human papilloma virus is the single most important risk factor for invasive cervical cancer.

STDs also substantially increase the risk of HIV transmission, boosting the likelihood of infection three- to fivefold. The number of new HIV infections are increasing most rapidly among women, adolescents, and within

minority communities.

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I also believe it is essential that we develop microbicidal products, products to prevent transmission of STDs

with an emphasis on methods that women can afford and control without the knowledge of their partners. I have

sponsored legislation since 1990 to increase funding for HIV/AIDS research focused on women.

These are issues that receive less attention in our research and prevention agenda, and yet, they represent 

very serious women’s health concerns. Our challenge is to identify and respond to the many health needs of

women over the full span of their lifetimes.

The Women’s Caucus continues to ensure that Congress focuses on women’s health. Earlier this year I sponsored a bill, cosponsored by Nancy Johnson, Anita Lowe, and Eddie Bernice Johnson, and Olympia Snowe in the

Senate, to cover bone density tests for diagnosis and prevention of osteoporosis under Medicare. I am delighted 

to say that that is now law. It became part of the Balanced Budget Act in Congress. There will now be annual 

mammography screening under Medicare, a long effort begun by Caucus members years ago. 

Bipartisan efforts are currently underway on issues such as preventing “drive through” mastectomies, expanding

osteoporosis research and health insurance coverage, ending discrimination against battered women in insurance,

and banning discrimination based on genetic testing. Caucus members have introduced legislation to increase

funding for a number of women’s health concerns, including breast cancer, cardiovascular disease, lupus, and 

DES, just to mention a few. 

The Women’s Caucus held a hearing on the need for more and improved contraceptive methods for women 

to meet their needs throughout their reproductive lives. Female sterilization is the most commonly chosen form 

of contraception in this country, a fact that I find shocking. Almost one-half of all unintended pregnancies result

from ineffective contraception, and 44 percent of unintended pregnancies in this country result in abortions.

Incredibly, half of the fee-for-service insurance plans do not cover reversible contraceptive methods. We must 

work to eliminate the barriers to this research and to expand our research efforts in this area.

These are just a few of the successes and the current efforts that are underway in Congress to address the

needs of women’s health. Our Caucus just celebrated 20 years as a bipartisan force in Congress, and we will 

continue to be there for you and look forward to receiving the priorities identified by this critical conference 

for an agenda for the 21st century. 

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REMARKS Louise M. Slaughter, M.S., Representative, U.S. House of Representatives

Those of you gathered here already know what a landmark event this is. Most of you have played important

roles in bringing us to this point. Six years ago, a similar gathering convened in Hunt Valley to map out 

the coming decade of research on women’s health. It was an ambitious undertaking, but the agenda set 

at Hunt Valley has advanced beyond many people’s wildest hopes and expectations. This conference is the next

generation of that critically important endeavor. I am proud that we have made so much progress in just 6 years 

that we already need to update the national women’s health research agenda.

The original Hunt Valley conference took place in 1991 — a challenging year for women’s health. Congress had

worked for over a year to craft the NIH Revitalization Act, a seminal piece of legislation that proposed to bring new

focus to the NIH’s research on women’s health, allocate new resources for this purpose, and establish a permanent

Office of Research on Women’s Health. That bill was vetoed by President George Bush, who called it “unacceptable” and “objectionable,” singling out the provisions on women’s health for special criticism. President Bush stated

that the NIH Revitalization Act was “not necessary to increase support for research targeted at women’s health needs.”

This happened about the same time that then-NIH Director Bernadine Healy was quoted as saying that at NIH

“Women’s health has always taken a back seat.”

At the same time, issues like breast cancer and osteoporosis were finally penetrating the American public’s 

consciousness. I spoke to the Komen Foundation that year and congratulated them on raising $11 million for

breast cancer research. The National Osteoporosis Foundation was a youthful organization, working uphill to 

build membership and educate the public. At speaking engagements, I was pointing out to groups that there 

were more shelters in our nation for abused animals than for battered women and children.

That was 1992. This is 1997. What a difference 5 short years can make!

Today we have a permanent Office of Women’s Health Research at NIH, directed with leadership and flair 

by the incomparable Dr. Vivian Pinn. Dr. Pinn and her staff have proven time and again how important a central

office on women’s health is for NIH. The office coordinates the interdisciplinary aspects of critical women’s health

research into breast cancer, DES, lupus, and AIDS. It has worked to give women’s health greater prominence in 

medical school curriculum and move advances in women’s health research from the laboratory to the bedside. 

It has advanced research and education on women’s health through conferences and publications, as well as the

sheer persistence of its staff. We all owe Dr. Pinn a debt of gratitude for her unceasing labor and dedication to 

the health of our nation’s women.

Further, we now have offices of women’s health at other federal agencies like the FDA, CDC, and AHCPR. 

The HHS Office on Women’s Health has launched major education campaigns like Healthy Women 2000 and GirlPower! to educate women of all ages about their special health needs. Women are finally beginning to receive their

due as half of the nation’s population and half of the taxpayers contributing toward federal biomedical research.

The private sector has traveled a long, productive road since 1991 as well. In the advocacy community, the

Komen Foundation is expected to raise more than $30 million for breast cancer research in 1997, more than 

triple the amount it raised in 1991. The National Osteoporosis Foundation is a nationally known organization 

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY
with a membership of more than 150,000. Dozens of women’s health advocacy groups have formed and gained

new prominence, while organizations like the American Heart Association have established a new focus on the 

women’s health aspects of their issues.

Health care providers are making progress as well. Today one-third of all hospitals have some kind of women’s

health center, up from 19 percent in 1991. Increasing amounts of private research dollars are being spent on 

treatments for disorders particular to women, as well as diseases that afflict women differently from men.

We have come a long way in the past 6 years. The question we are here to examine today is: Where do we 

go from here?

Part of the answer to that question is simple — we keep traveling along the same course that we have followed

since 1991. Despite major advances like the discovery of genes for breast cancer and drugs to treat osteoporosis,

we still have not cured these diseases. We do not understand what causes the 90 to 95 percent of all breast cancer

cases that are not genetic. We still do not know whether DES has consequences for the children of the women

exposed to the drug in utero. We do not know whether it is safe for women with lupus to take estrogen after

menopause. Women must still rely on the neolithic technology of the mammogram to detect breast cancer. We

must continue our pursuit of new and innovative ways to prevent, diagnose, treat, and cure these disorders.

We must strike out in new directions as well. The last 6 yeas have certainly proven the old adage, “The 

more we learn, the more we learn how much we have to learn.” In my view, the Federal Government should 

take on the responsibility for educating women and health care providers about diseases that are traditionally 

considered men’s diseases and not women’s.

Despite the prevalence of breast cancer, heart disease remains the number one killer of American women,

claiming one quarter of a million women’s lives annually. A recent study showed that older women feared cancer

more than any other disease, although they are at higher risk proportionally for heart attack. Though ovarian 

cancer will affect more than 25,000 women this year, colorectal cancer will strike almost twice as many.

We must begin educating women about these health risks and the steps they can take to ensure they receive

appropriate care. Women who have heart attacks are less likely than men to receive the most aggressive treatments,

despite similarities in age and severity of illness. Colon cancer is one of the few cancers we can actually prevent if

polyps are detected and treated early. I intend to begin a major effort to educate women about their risk for colorectal cancer and appropriate prevention measures. But NIH should play a central role as well, demonstrating

through its research agenda the Federal Government’s commitment to these crucial women’s health issues.

Another women’s health taboo that should be broken once and for all is menopause. Too many American

women have suffered needlessly in silence because they did not have access to accurate information about menopause. Too many women still view the symptoms of menopause as a trial they must bear alone and not share 

with anyone, even their doctor. Today, hormone replacement therapy can offer relief to many women for not 

only symptoms like hot flashes and mood swings but may also afford future protection against heart disease and

osteoporosis. However, hormone therapy is not right for all women and some may need to balance its benefits

against a possibly raised risk for breast cancer. We must continue working to transform menopause from a 

condition somehow unfit for discussion in civil society to a natural progression of the aging process that 

should be addressed and, if appropriate, treated by a medical professional.

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This is just a small sample of the issues women’s health research should face as the field passes its 

infancy and begins to mature in the coming years.

It is too early to celebrate victory. We still have a long road to travel toward equity in women’s health. But 

we have made a very good start, haven’t we, my friends? I look forward to working with you all to advance

women’s health into the 21st century — not as an afterthought to biomedical research, but as a full partner 

in our nation’s quest to improve human health.

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY
Louis Stokes, J.D., Representative, U.S. House of Representatives

REMARKS Presented by Fredette West

I

am very pleased to have this opportunity to speak to you on behalf of Congressman Louis Stokes 

about an issue of importance for many of us, our families, our communities, and our nation — 

women’s health.

The Congressman has been following the forum and is glad that there is such diversity in the participation

represented throughout the workshop. Your presence here today is evidence that you join the Office of Research 

on Women’s Health in its commitment to ensure that our nation’s racial and ethnic minority communities are

included in this important discussion.

The participation of 55 public witnesses in these talks is also encouraging. It speaks highly of this program and

of the efforts of the Office of Research on Women’s Health to improve the status of all women across this country.

Congressman Stokes applauds Dr. Vivian Pinn on her outstanding leadership of the office, as she has worked

very diligently to guide the development and implementation of the national research agenda on women’s health.

Women’s health is one of the most important issues facing this Congress and our nation.

As a member of the House Appropriations Subcommittee, which funds health programs, Congressman Stokes

indicates that we still have a long way to go; however, substantial progress has been made. As a result of the subcommittee’s action on the appropriations bills for the Departments of Labor, Health and Human Services, and 

Education, the recently enacted fiscal year 1998 appropriations measure includes $18.4 million for the Office 

of Research on Women’s Health.

For the Ryan White AIDS Program, the bill provides more than a billion dollars. There is $145 million for

breast and cervical cancer screening, $683 million for maternal and child health development block grants, and

well over $13 billion for NIH as a whole. These are just a few programs that are funded under that particular 

appropriations subcommittee.

As chairman of the Congressional Black Caucus Health Brain Trust, Congressman Stokes is particularly 

proud of the role that the CBC has played and continues to play in women’s health. Since its founding in 1971, the

Congressional Black Caucus has worked diligently to address the health challenges that impact African-American women, families, and communities across this country. In fact, the Congressman recently convened a special

health forum that closely examined issues regarding the health status of African-American women entitled Saving 

our Sisters. If you look at the statistics, you will discover that compared to their white counterparts, AfricanAmerican women still suffer a much more compromised health status. 

For example, African-American women are more likely to die of breast cancer. This is, in spite of the fact 

that they experience a lower rate of incidence of this disease. 

African Americans between the ages of 35 and 47 are 38 percent more likely to die of a heart attack. AfricanAmerican women, college-age and educated, are three times more likely to have a low-birthweight baby. Infants 

born to this group of mothers have an 80 percent higher risk of dying during their first year of life.

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And during 1996, 59 percent of all AIDS cases in women were reported among African-American women.

Congressman Stokes wants you to know that with your help and with the steadfast efforts of the Office 

of Research on Women’s Health, we can make significant strides in reducing the health status disparity of 

minority and disadvantaged women.

Again, Congressman Stokes sends you his regrets and looks forward to your sharing with him the 

recommendations of this conference. Such recommendations would be used to help formulate legislative 

agendas and amendments to various bills. 

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Audrey T. Haynes, M.S.W.

Deputy Assistant to President Clinton

REMARKS Director of the Office for Women’s Initiatives and Outreach, The White House

I

t is a great pleasure to be here, and an honor to be in a room with such a wealth of knowledge and information and enthusiasm about the women’s health care field. Obviously, health care in general is of interest 

to me, having just served as Deputy Secretary for Health in our state. For those of you who deal with State

issues, all states, including my own Kentucky, are wrestling with many health care issues today. Nationally, I have

been very interested in what all the women’s health offices throughout this administration are doing, and we are

bringing all the directors of all the women’s health offices throughout the Administration to meet on such issues.

The President has a very positive track record on women’s health, and he wants to continue that track 

record to make positive improvements and to put into place some important programs and a research agenda,

which I know you are working on. You and the President are looking at not only the short-term but the longterm research needs.

Women’s health is not just about the health of one woman, but it is about the health of our families and 

the health of this country. It is my goal in the Office for Women’s Initiatives and Outreach to make sure that

women’s health continues to be at the top of the White House agenda. 

You have a great advocacy community, and many of you are probably advocates as well as researchers on

women’s health. We have a great relationship with the women’s health community. These advocates speak loudly 

and clearly and often. They always have great things to say, and I always listen. I listen very closely. They always 

provide great information, and I know that we will continue to work with them.

Again, I wish you the very best and a very positive meeting.

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Francis Collins, M.D., Ph.D.

Director

GENETICS, GENOMICS, AND WOMEN’S HEALTH National Human Genome Research Institute

Genetics is a very important part of the research agenda for women’s health because genetics has become

the central science of medicine in many ways. We are engaged in a genetic revolution, which is already

underway, and women are in the front lines of this revolution. Many of the advances that seem to be

occurring in genetics are having an impact on women, perhaps disproportionately due to their numbers from the

discovery of the BRCA1 gene to all of the focus on reproductive genetics, where clearly women have more than

their share of the dilemmas to wrestle with. 

It is going to be the case, no matter how clever we get, that, in fact, gender and biology are inextricably intertwined. We know a lot, but we need to know a lot more about why that is. We certainly have learned to appreciate

that inheritance patterns are not so simple as we once thought, and issues such as mitochondrial inheritance and

imprinting and non-Mendelian kinds of inheritance are now finally receiving the kind of study that they did not

get before because people had not quite appreciated their significance. 

For many diseases, gender plays a role. We have to be sure that when we make that statement that we are 

not immediately jumping to the conclusion that that is because of genotype. Because certainly in some instances 

that is not true, and it is the different environmental exposures that actually account for the difference in risk.

We will not reach the point of deciding where agenda is irrelevant to risk of disease because, after all, there 

is a very strong biological basis for many of the predispositions that people are beginning to uncover, which differentially affect the sexes. That is in contrast to race where we are increasingly coming to the rather exciting realization that there is very little reason to define race as a real entity at all and that, in fact, our similarities are so much

greater than our differences. Similarities between individuals who we socially designate as being of different racial

backgrounds are, in fact, as great as similarities within groups of individuals who self-identify as being of the same

race. The whole concept of race is in evolution and will be from the point of view of science moving in the direction of being less and less relevant. The way that our cultures have developed over time, we will be talking less

about race, which is going to challenge us socially.

Clearly, when it comes to women’s health one of the challenges for researchers will be, as everywhere else, 

the distinction between what is genotype and what is environment. Now, your working groups (all except the 

one on careers) are focusing on particular areas of research that have some genetic components. I am not arguing 

that they are all genetically predetermined, which would be absolutely indefensible, but everyone of these particular areas of medical research clearly involves factors that are written with the DNA double helical sequence. 

As you plan this agenda for the next century for women’s health research, it will be very critical to include a 

consideration of how genetics is going to push that agenda forward.

The human genome project is going to make a very significant contribution to what is possible. The genome

project has the three major goals, which are to get genetic maps, physical maps, and the DNA sequence. The genetic maps are essentially done, the physical maps are 98 percent done at the level that was originally defined as

being needed, and the DNA sequence of all three billion base pairs of the human genome is just getting underway. 

It would be hard to find individuals working in the field who are not pretty confident that we will achieve this 

goal of the complete sequence of human DNA by the year 2005.

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That will be quite a milestone that will profoundly alter the way that research is done. We spend so much 

time these days cloning and sequencing genes in research laboratories, and we will have at least a reference 

example of every gene. Great effort is being put into making sure that this information is publicly available. 

Laboratories are depositing their data in electronic databases in a fairly unassembled form every 24 hours 

so that people who want access to it can get that.

You might ask, whose sequence are we doing anyway, and is it a man? We had a very interesting discussion

about this because we really had to decide what should be the source of the DNA that is going to be used to produce that first sort of reference genome. We decided it was not very sensible to go out and find a perfect specimen

because there are not any; we all have flaws. We decided that it would be fairly dangerous for the whole sequence

to come from a single person because that person’s DNA sequence would sort of be laid out. Instead the proposal

was to put out a call for volunteers to come in to have DNA obtained, and then we would have a subset of those

individuals have their DNA actually turned into the libraries that are being used for the human genome sequence

analysis. Their identities are anonymous. 

Obviously, however, it will possible to determine their sex. There are slightly compelling reasons in that sperm

makes a particularly good source of DNA because of the absence of somatic rearrangements that might arise in

DNA from blood. The human genome project is going to focus on men. So, in fact, the source of the DNA that is

being used for this project will be ethnically somewhat diverse, although we do not really know the ethnic origin

of the individuals, and will be gender diverse. The point of this first sequence is to get the 99.9 percent that is the

same among all of us identified. The part that is responsible for variation will be the next phase to understand.

This is a very exciting development, but the real point of the genome project is to make it possible to understand disease, not just clone genes, but use that information medically to develop better diagnostics and better

therapies. As these gene identifications are happening — and they are happening with great profusion these days 

with as many as about 25 new disease genes being identified this year — we ask what are the pathways that have 

to be traveled after that identification has occurred. The more immediate ones are often in the diagnostic arena

where we are able to make predictions about who is at risk for something or whose children are at risk for 

something. The longer term ones are to develop this into therapies.

How does all this interrelate, particularly to research on women’s health? I will mention four topics. The first

one is sort of the traditional one where people consider the interface between genetics and women’s health to be

most strong. I think in the past a vast quantity of the dialogue that occurred between genetics and women’s health

was in this arena. This is changing as others come along, but this will continue to be a major area for discussion. 

Consider, for instance, a recent NIH consensus development conference on genetic testing for cystic fibrosis.

CF is a disease that is quite common in the Caucasian population, where 1 in 25 or 1 in 30 Caucasians are carriers

for this recessive disease, and less common for other ethnic groups. The gene was found 8 years ago. We know

that there are lots of different mutations in the gene, but if you test for about 30 or 40 of them you can identify

roughly 85 percent of the carriers.

Now, two carriers who have a child face a 1 in 4 chance that that child will have cystic fibrosis, and so 

immediately after the gene was identified, people began to discuss the possibility of offering carrier testing 

to the general population. NIH funded a variety of pilot projects in various settings to try to find out what 

was the interest in the possibility of CF carrier testing, outside of those who had a family history.

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The discovery was that there was relatively little interest, except in one setting: women who were coming 

in for their first prenatal visit who were sort of triggered to begin to think about genetic issues by the obstetrician 

talking to them about neural tube defects and other disorders. Then if offered this possibility of finding out about 

CF carrier status, many of them did, in fact, turn out to be interested in proceeding down that pathway.

At the conclusion of this consensus conference, which looked at all of the data that had been carried out

through those pilot projects, the finding was that there is now sufficient scientific justification to begin to offer 

CF carrier testing to individuals outside of a family history. In fact, that sort of stirred the community up considerably. Up until then everybody had said that would be premature.

Why is this relevant to women’s health? Many of the proposals about how to carry this out suggest that the

most efficient way to identify couples who are at risk is to begin by testing the woman for carrier status, and only 

if she tests positive do you then try to identify the partner and determine his carrier status. It is sort of sequential

sampling process, as opposed to testing the couple up front.

There are consequences to that, not yet have fully explored, on the burden of the decisionmaking, the burden 

of the possible stigmatization of women who are finding out their carrier status, whereas their partners only are

offered that opportunity if the woman turns out to be positive. This, I think, is an area of considerable possible

utility, as far as research studies because CF is the first example of a DNA-based carrier test that is being offered 

on a large scale or will be probably in the course of the next 2 or 3 years. We have not yet fully explored what 

the consequences might be of that kind of leap into the new genetics on such a large scale. I would certainly

encourage you in your deliberations to consider what opportunities are there that ought to be followed up on. 

One of the issues really is research on pregnant women in the first place. This has not been an easy area. 

There have been examples, for instance, of the testing of drugs, which have left out, in many cases, women 

of childbearing age because of fear of possible impact on pregnancy, a well motivated sort of original idea, but 

obviously one that has been carried to an extreme. Women are excluded, particularly pregnant women, even 

in circumstances where there is no medical, physical risk to the fetus, just because in a patronizing sort of 

way researchers say, it is a stressful time and women do not need to be bothered then.

On the other hand, there is the other end of the spectrum where, in something such as CF carrier screening,

there seems to be almost a targeting of women. It is easy to find access to them, and they are likely to participate

because they are motivated about the health of their unborn child. How do we sort of balance this and figure out

what is the appropriate ethical stance to take when it comes to this kind of study? I think there are some interesting questions there as well.

The second topic, and probably the one that gets the most media attention right now, is the area of pre-symptomatic testing. Women really are on the front lines here, in particular because of BRCA1 and BRCA2, and many

other examples that will be coming along. Just to remind you, in our rush to be enthusiastic about the research

advances that have occurred in breast cancer with the discovery of BRCA1 and 2, let us not forget that 90 percent 

of breast cancer arises in women who do not have alterations in those particular genes. We need to work much

harder to understand what is going on there, because there probably are weaker genetic factors at play in that 

90 percent. They are harder to uncover, but in the aggregate, they may involve more women than the relatively

uncommon but highly risky BRCA1 and 2 mutations.

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We critically need to find better answers of what to say to women who turn out to have mutations in 

BRCA1 and 2. We have the diagnostic ability now to determine this, and the test is commercially available, 

but we are woefully ignorant about exactly what options are effective in this circumstance.

A paper from the Cancer Genetic Studies Consortium, an effort which has been funded by NIH and led by 

the Genome Institute but has had important support from the Office of Research on Women’s Health, reviewed 

the entire world’s literature on what we know about the effectiveness of frequent mammograms, of a prophylactic

surgery, either breast or ovarian surgery, and other options that might be offered to women in the high risk circumstance of having a BRCA1 and 2 mutation. Basically, the bottom line is we have very little data. There are anecdotal

reports of this kind of outcome or that kind of outcome, but the best you can do, as far as making recommendations, is say this is expert opinion. Expert opinion often turns out to be wrong after you have real results.

The National Cancer Genetics Network, which has gotten underway through NCI, will be looking at areas

where hopefully we will be able to develop better answers to these questions, which women desperately need 

to make their own decisions about what options are most appropriate.

Pre-symptomatic testing for cancer for men is going to be interesting. There has been this identification on 

the basis of at least a linkage analysis that there is a gene for prostate cancer on chromosome one. We are trying to

focus in on this and find this gene hopefully in the next not too many months. If that happens, we will then see a

situation where it will be possible to make predictions about which males have a very high risk of prostate cancer.

I think there will be some fruitful areas of investigation to compare those two arenas. Will we see proposals 

for men to undergo prophylactic surgery for prostate cancer risk? I suspect not, and why is that? Does that say

something about the difference in the medical circumstances or more about the way in which we view dispensability of organs, if you are talking women versus men. I think there are some very interesting questions there.

An interesting thing to look at, which as far as I can tell has not been considered, is pick a disease where the

disease itself is not gender-specific, and there is a strong heredity predisposition. In colon cancer, for instance, we

now have several different genes that carry a high risk of colon cancer, for which testing is available. What happens

when somebody is identified at high risk, and they are offered the various options of surgery or colonoscopy on 

a regular basis. Is there a difference between the men and the women, in terms of what choices are made, and, 

if so, is there a difference because of the way that the risk is presented by the care givers, or does it reflect some 

other aspect of how decisionmaking is made between men and women. I think this is a very interesting area 

to look at and would be an important agenda item for the future.

Up until now, most of our genetic analyses have been for things like BRCA1 and 2, where we pick a relatively

common disease and then dissect out of it a subset of individuals who have essentially a single gene disease. If 

we have an altered copy of the BRCA1 gene, we are going to see a pattern in the family which looks Mendelian.

The real challenge is to go after the much more complicated situation where many genes are involved, but each

one of them has a relatively modest effect. The other 90 percent of breast cancer probably has some polygenic

effects, and virtually every disease that has an effect on women’s health will have some polygenic contributions.

The exciting aspects of this is we are on the brink of being able to attack those situations with considerable

power over the next 5 or 10 years. We will be uncovering those predispositions, which have an effect on very 

large numbers of people. An example is autoimmune disease. We do not understand why autoimmune diseases 

tend to be more common in women than men.

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An exciting recent observation is to try to see where are the genes that predispose to autoimmunity. We 

collect families in which more than one individual has the disease. We scan the entire genome with large numbers of these genetic markers, and we try to identify a region that tends to predict who has the disease and who

does not. This is a sort of a linkage study often done with affected sib pairs. The results are often at the borderline 

of statistical significance because the genetic predispositions may be quite weak. This study scanned the results

from about 20 different studies on different diseases and looked at them side by side to ask are the genes that 

predispose to multiple sclerosis, type one diabetes, rheumatoid arthritis, and lupus totally different or are 

there some similarities here? 

The MHC is involved in virtually all of those, and it could be argued that autoimmunity might have some 

common basis and then specific outcomes based on some modifications of that common basis. The various 

human chromosomes are areas where there are clustering of disease predispositions for different autoimmune 

diseases, which happens in a non-random way. This suggests that there are going to be common predisposing

genes that are involved in autoimmunity across the board. Finding those would be an extremely high priority.

Linkage studies are terribly difficult. Sometimes more promising efforts are association studies, where you 

pick a gene that you believe may be involved in a particular disorder and you try to find variation in that gene 

and then see if that variation associates with a particular disease. An exciting example that has not gotten much

attention is osteoporosis, obviously a disease of great interest in women’s health because 80 percent of those with

severe osteoporosis are women. A study has been done to look at a variation in the gene for type one collagen.

There is a regulatory region of that gene that is probably responsible for how well the gene is transcribed and how

much protein it makes. There is a singular nucleotide, which varies in the population. In some people, it is a G,

and some people, it is a T. They are calling one of those alleles “big S” and the other “little S.” They are looking 

to see what is the association of the genotype with severe osteoporosis demonstrated by a vertebral fracture. In the

study, the vertebral fracture group has a larger number of people who are heterozygous for little S or even homozygous for little S, which you do not find at all in the controls, suggesting that this variant, which is the one that 

would potentially reduce the transcription of this gene, is a significant risk factor for osteoporosis.

Here is a disease that we think we could prevent, if we knew who was at highest risk. Here is an area where 

I think considerable research opportunities would exist, first to confirm that this result is right, then to try to 

consider what kinds of interventions would be appropriate for those found to be at risk.

Association studies of this sort, which we could never have found by linkage analysis because the effect is 

too weak, are very exciting when you get a result. The problem is most of the time we do not know where to 

look. If you were trying to figure out, for lupus, for instance, what genes are involved, what would you pick? 

We could make some guesses, but probably the things that are involved would not be on the list.

A new strategy is to go out and try to identify variation in the human gene element in a much more systematic way than we have done before, so we can do these kinds of association studies without having to be 

able to guess what the right genes are. 

We would like to do two things. One would be to directly go out and identify the variations that occur 

in coding regions of all of the 80,000 genes or as many of them as we can get our hands on as soon as possible. 

It is not possible to do the whole thing because at the present time we only have full length copies of maybe 5,000 

of them, but we could start there. Every one of those genes will have the possibility of a common variant, and

those common variants may, in some circumstances be associated with disease because they change the function 

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of the gene. With the catalog, we could do what I explained we did for osteoporosis without having to get 

lucky by making the right guess.

Even if you cannot do that for all 80,000 genes, there is an indirect way to get the same result. If we had a 

very, very dense genetic map, as shown by each one of these tic marks, we could identify a region of a chromosome that is predisposing to illness, even if we had not identified the precise base change that was itself the 

cause and effect contributor. By identifying the neighborhood, we can get to about the same point.

An initiative called SNIP is about to get underway and will probably result in the generation of such a catalog

over the course of the next few years. It will make this kind of genetic analysis to identify genes that have weak contributions to common disease much more plausible. Those genes when they are discovered will have an influence

on large numbers of people because these will be common variants that maybe 10 or 15 percent of the population

have, not like the current situation where you study a relatively rare variant that has a very large effect.

What about therapy? Clearly, genetics will continue to play a role. It is not possible these days to run into 

a pharmaceutical company that does not have a genomics division, because they are counting on genomics and

genetics to be the source of their new drug discoveries. Virtually all of them are planning for the day where gene

testing will be used to identify who is a particularly vulnerable subject to the toxicity of a particular drug and 

who is a particularly good subject for a particular drug. The notion of individualized drug therapy based on 

the genetics of the host is a very real concept, which will probably come about in the next decade or two.

I would predict that gender will have a large effect on that kind of analysis. After all, that is a particularly 

powerful set of genetic differences. If we see a pharmaceutical company that is proposing to do this, not taking 

into account gender of the subjects and not including sufficient numbers of both genders, then you might 

end up with a result that is not, in general, the one you want. 

A common variant in a blood clotting factor, called factor five, produces ranine instead glutamine. We find 

this in 3 percent of the population, but if we look at patients that have had a significant episode of venous thrombosis, you find it in 21 percent of them. People who have one copy of this, probably have a five- to tenfold increased

risk of thrombosis. The homozygote may be as much as 100-fold increase, and there is some sketchy but intriguing evidence that oral contraceptives may unmask this predisposition. At least one editorial has suggested that all

women ought to be tested for this particular variation before going on oral contraceptives or other estrogen therapy.

Here is the possibility of genetics and pharmacology interacting with each other, and yet I think there are many

questions to be asked there about whether this is an appropriate step to take, most particularly in the area of 

the ethical, legal, and social issues. 

This brings us to the fourth and final area. As I said, women are in the front lines of the genetic revolution. 

I am afraid that also means that they have been particularly vulnerable to misuse of that information when it 

comes to things like health insurance. I cannot resist the opportunity to make the case that this is a problem we

have not yet solved, that women are particularly in a circumstance where this is being used against them. This 

is in part because BRCA1 and 2 testing is out in front of a lot of other opportunities, and I think also because

women are more likely to be in a situation of less than a vigorous health insurance and, therefore, more prone 

to be discriminated against if some result is discovered about them.

With the Kassebaum-Kennedy bill, we now have protection for individuals who are covered by group 

plans, but not sufficient protection in an individual plan. I think we collectively just have to fix that. I certainly 

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have enjoyed my experience with the National Action Plan on Breast Cancer working on this problem, but we 

still have to see it solved. There is lots of enthusiasm for doing it on both sides of the aisle, and both houses 

of Congress, but we cannot stop until it is done.

Genetics is sort of part and parcel of everything you are talking about today and tomorrow in your workshops. I think it would be inappropriate to try to pick out just one area and say well, this is where genetics 

really needs attention. It is probably all the way through there.

Women, I think, are going to continue to be on the front lines. I would like to see that happen in a way 

where the women are the victors and not the casualties. I think collectively we can do that, but we have to 

roll up our sleeves. We have to keep our eyes open, and we have to be resolved that that is the outcome 

we are going to settle for, and nothing less. 

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY
Karen Rothenberg, J.D., M.P.A

Marjorie Cook Professor of Law

Director of the Law and Health Care Program

SOCIAL, LEGAL, AND ETHICAL ISSUES University of Maryland School of Law

I

had the honor of working in Dr. Pinn’s office for a year, and she had the vision to let me work on genetic

issues. That gave me the opportunity to work closely with Francis Collins and Richard Klausner and to take 

a proactive role in setting the agenda for genetics. I would like to place Dr. Collins’ presentation into a broader

societal context. These are warnings that may dampen some of our enthusiasm about what might happen in 

genetics in the next few years. 

First, I caution you about “genetic myopia.” This is a blindness that occurs when we try to explain everything 

in terms of a genetic solution, a genetic answer, or a genetic cause. This can be very dangerous because it blinds 

us to other things that are affecting us. Individuals should not think that their health is so heavily determined by

their genetic makeup that changing their behavior will not affect their health. Thinking that we can not change 

our health status, no matter what we do, does not empower us to improve our health.

Secondly, we all need to be aware that genetic testing is not a “quick fix” in and of itself. It is a means toward 

an end — better or improved health and reduction of morbidity and mortality. It is not an end, and sometimes 

the commercial market may lead us to think that is the stopping point. 

Third, we want to be careful about not perpetuating a genetic underclass. For example: Those who have 

access to prenatal care have access to prenatal testing. Those who do not have prenatal care do not have access 

to prenatal testing. Those who are involved in a research protocol may be able to get testing, but then may not 

be able to benefit from any of the information. If they do not have insurance for a prophylactic mastectomy, or

they do not have funding to get mammograms more often, what good is this information? Will we continue 

to perpetuate even more divisiveness in our country?

The fourth issue that concerns me, particularly with respect to women, is accountability. If this information 

is available, do we have a duty, particularly with pregnant women, to get all this genetic information? Over the 

past 20 years, we have focused mainly on pregnant women. We have had genetic information on pregnant women,

and my prediction is this will continue because they are the targeted audience that can be marketed commercially. 

Fifth, a social construct is developing that I call “genetic identity.” It is the Jewish gene for breast cancer, the

African-American gene for sickle cell trait, and the Native-American gene for alcoholism, and so on. The irony is

that to conduct good research, particularly in genetics, you may have to focus on certain ethnic groups. Subgroup

population analysis is very important to good research, but how are you sure that you do not target and stigmatize 

a group so much that these people say we have had enough. How do we really do good research that is meaningful to those particular groups and at the same time not injure them?

Within this societal context, the major legal, ethical, and social challenges include: informed consent, discrimination, privacy and confidentiality, and family rights and responsibilities. 

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Many unanswered questions create challenges for the informed consent process. For example, in predictive

genetic testing, the value of the predictive information is unknown. We have very little data on its value in terms 

of the individual’s health. We risk misinterpretation, both from the perspective of the consumer and from the 

perspective of the provider. We have limited clinical data on the effectiveness of prevention and intervention 

strategies. The impact of predictive testing on changes in health behavior is also unknown. If, in fact, one 

has a susceptibility for a particular disease, for example, lung disease, is one more or less likely to smoke? 

In addition, it is difficult to quantify and qualify the social risks of genetic testing and research. How much 

discrimination is there? What are the privacy concerns? How does genetic information change family relationships? Do people experience group stigma? All these social questions are beginning to emerge. We must still 

face the unforeseeable risks and benefits that are yet to be identified. In the 21st century we must continue 

to address the complexity of the social, legal, and ethical implications of genetics.

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY
John C. Fletcher, Ph.D.

SOCIAL AND ETHICAL PRIORITIES FOR Professor of Biomedical Ethics

WOMEN’S HEALTH RESEARCH AND HUMAN GENETICS University of Virginia

I

am pleased to respond to Dr. Francis Collins’ talk, in which he emphasized that women’s health research and

research in human genetics are interdependent. I agree with his main points and consider myself a strong

supporter of each. My response to him and to the movement to improve women’s health research is to offer 

a framework of seven social and ethical priorities that have claims on advocates of women’s health research and

genetic research. These claims remind us that we are all part of a larger whole, and when we forget it, our causes

can be harmed by lack of foresight and political isolation.

Universal Primary and Preventive Health Care: Incrementalism — The Prevailing Approach

The overriding priority is to remedy a longstanding condition of unfairness of access to adequate primary 

and preventive health care. America’s moral paradox in health care is stunning technical success (symbolized by

the Human Genome Project) and the nation’s failure to serve all citizens adequately. The connection between the

work of this conference and health care reform is that the longer reform is delayed, the less advances in women’s

health and genetic research will be broadly perceived as benefits. The reason is simple. Many of these advances will 

be beyond the reach of many uninsured and underinsured American women and children. We are here to renew

our nation’s efforts in women’s health research. Yet, how a nation treats its children is an indelible index of its real

moral practices. Today, there are at least 11 million children without health insurance.1 They comprise one-fourth

of the more than 41 million Americans who lack insurance. A sound body of evidence documents the inadequate

health care received by uninsured families with children as compared to the insured.2 Congress’ action to remedy

the problem has ambiguities and problems of its own.3

When one adds the underinsured and enrollees in Medicaid programs, almost 90 million Americans, more than

one-third of the population, have inadequate preventive and primary care. It is unrealistic to expect that advances

in diagnosis and treatment that are generated by women’s health research and genetic research will benefit these

persons, because most of them will be unaffordable. So, there is a great gap between the expectations that the health

of all Americans will benefit from advances in women’s health research and genetics and the reality. Recognition 

of this gap will cause more bitterness. Great bitterness already exists, because individuals and families can lose

their life savings from a single, catastrophic illness or accident. Also, these insecurities are being exacerbated by

aggressive competition by large for-profit managed care companies that underbid health insurance contracts with

employers and then create allocation policies and financial incentives for physicians to acquiesce toward the least,

rather than the best, that can be done for patients.4

The basic problems in health care reform are not basically economic. As a nation, we now spend one trillion

dollars in the health sector, more than enough to afford adequate primary and preventive care. The problems lie 

in moral vision, mistrust of government as a partner in reform, and a badly unbalanced health policy. Permit 

me a few words on each of these causes.

What is the prevailing moral view of health care? Is it, as I and others who want reform see it, an obligation of society towards all its citizens? Or is it mainly understood as a commodity to be bought and sold in a free

marketplace whose excesses are regulated by government? The business aspects of health care must be governed 

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by its characteristics as a moral relationship, or else the whole enterprise suffers. Adequate health care is a basic

social good necessary to enjoy other social goods — e.g., education, family life, work, etc. However, this is not 

the prevailing moral vision of health care that underlies U.S. health policy or its practices.

Moments of sobering reality have arrived for leaders in U.S. medicine and the nation’s communities.5 The 

professional integrity of clinicians has greatly diminished. Race and class divisions are starker in the nation’s communities because the majority economic and political forces channel health care into three tiers for the poor, a

slowly vanishing middle class, and the affluent.6 Hopefully, the bitterness about health care inequities can be 

translated into politically effective action. Only a long-term commitment to reform will moderate and alter public

opinion with a vision of adequate preventive and primary health care as social goods and a moral obligation 

of the state and national communities to which we belong as Americans.

Our nation’s health policy is heavily one-sided. There is not enough money to afford both the array of intensive technological services whose imperatives so strongly drive the present system and a vastly improved preventive and primary care system. To remedy the structural imbalance of a wrong health policy requires correction of

national priorities. Jacobs7 diagnosed the major obstacle to health care reform as a national health care policy for 

a “supply state” that continually expands the supply of technically sophisticated health care to the detriment of

attention to access to good preventive and primary care. Increasing genetic services (a good thing) will further 

add to the costs of technology. However, the policy results in deep political obstacles and fractured interest groups

that provoke leadership elites to refuse to make access the priority and supply responsive to access. Compared

with other advanced nations, the United States has both failed to create an adequate system of preventive and 

primary care or to provide access to adequate care within the existing system of health care. The structural incentives that promote the welfare of the “supply state” need to be radically altered to promote better access and supply 

of preventive and primary care services. This will require reengineering and downsizing a vast area of the health 

care sector heavily invested in acute care and intensive services. Long-term structural reforms guided by an 

access-guided health policy are needed.

Iglehart,8 an astute observer of health care, described a “new era” of incrementalism after the failure of the

Clinton health plan, i.e., modest reform efforts and managed care. Blendon, Brodie, and Benson9 gleaned lessons

from public opinion surveys about the failure of 1994. Although Americans wanted health care reform in 1993,

they feared that the Clinton plan would limit choice of physicians and hurt them personally. Furthermore, Americans were deeply cynical about national government as an agent of change. Clearly, this trust must be rewon over

the years, because there cannot be a national resolution without government as a partner and the ultimate arbiter 

of what constitutes adequate primary and preventive care.

In the interim, an incrementalist approach may be more cost effective and generate more public trust when

done experimentally at the state and regional levels, where the word “community” has more meaning than in 

the context of one sweeping national strategy.

Inclusion of Women in Clinical Trials

The second priority is the one that originally brought us together. Progress has clearly been made in inclusion 

of women in clinical trials, but there are still great distances to travel. Congress and NIH guidelines now require

evidence of such inclusion in NIH-funded trials.10 ORWH’s report on inclusion in extramural trials (April 11-12,

1996) does indeed reflect real progress in that 92 percent of grant applications satisfied the inclusion guidelines.

However, an institute by institute comparison would help. FDA reports indicate progress in pharmaceutical trials

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on inclusion of women, but their data gathering is not coordinated with NIH. The two agencies pooling and 

analyzing data together would yield a much more informative picture.

Enhancing Biomedical Research Funding in an Era of Managed Health Care

None of this research can occur without financial support. Managed health care systems are not currently

doing their part to support the costs of biomedical research. They are making profits but not reinvesting in the

research sector. Academic medical centers are also suffering significant losses in research dollars due to this condition. Congress may want to remedy this deficit for tax measures on managed care systems to benefit research.

Also, the national trust fund for medical research is an idea whose time is coming.

Reshaping a National Agenda for Women’s Health Research — The Role of Gender-based Biology

The fourth priority is the development of the science base for women’s health research. This means advancing 

the scientific study of gender differences in the pathophysiology, diagnosis, treatment, and prevention of human

diseases, i.e., gender-based biology. Such studies focus on the biologically based differences between males and

females over the whole range of issues that matter to scientific medicine. This concept is revolutionary in its 

impact on clinical medicine. Gender differences of significant clinical relevance have already been discovered 

in the immune system, susceptibility to lung cancer, use of pain-killing drugs, and treatment of angina. NIH 

and other federal science agencies should lead the way in creating this new knowledge base.

The last three priorities directly respond to Dr. Collins’ talk. 

Integrating Genetic Knowledge and Services into Mainstream Medicine

Prior to recent developments, genetics has been seen by most physicians as dealing with rare diseases

addressed by clinical genetics and reproductive medicine. Now that the Genome Project is deciphering the 

genetics of common diseases like cancer, cardiovascular disease, diabetes, and neurodegenerative disorders, 

it has the attention of mainstream medicine. At my university in the past two years, new genetic clinics have

opened in cancer, neurology, and cardiology. Vast changes will be needed to integrate this new knowledge 

and services into medicine, and it is impressive to see the National Cancer Institute moving rapidly in this 

direction. The task of educating U.S. physicians about the new genetics is formidable and exciting.

Removing Obstacles of “Genecity” (Fear of Genetic Information) and Fear of Discrimination 

(Insurance and Employment)

Many years ago, Alexander Capron coined “genecity” as a word to describe the reaction in many quarters of 

the public to advances in human genetics: fear, images of mad scientists and Nazi eugenics, and a sense (actually

there since Darwin) that there were no longer any secrets or mystery about human beings. I am concerned that

“genecity” also prevails among persons who need genetic services and among counselors who serve them, and 

in the warnings given by counselors that genetic information could be misused and be dangerous to a person’s

employment or insurance status. It is widely believed that individuals at higher genetic risk are also at high risk 

for denial of health or life insurance. The empirical evidence for genetic discrimination is sketchy at best. Two

studies have been published that found some cases of self-reported genetic discrimination in insurance and

employment. The respondents answered advertisements11 or were members of genetic support groups.12

Questions about bias and self-selection can be raised about these well-intentioned but limited samples.

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Other data, collected by Dorothy Wertz in 1997,13 indicate that the problem is not widespread if geneticists

and physicians can be trusted as good observers. Questions on the incidence of genetic discrimination were included

in a survey with 1,084 U.S. geneticist respondents. They had a median of 9 years experience and saw a median 

of six patients a week. They reported a total of about 550 individuals who were refused employment, let go from 

a job, or were refused life insurance on the basis of being a carrier or having a genetic predisposition. Further, a

sample of 499 U.S. primary care physicians in the United States who see 100 to 150 patients per week and are likely

to see their patients on an ongoing basis reported only a few instances of refusals of employment or health or life

insurance. Wertz’s data, also a form of self-reporting, leaves the impression that there are some cases but not many.

Looking at the data, my impression is that fear of genetic discrimination is more a function of the insecurity 

and uncertainty of one’s health insurance status in a nation that permits the inequalities discussed above under 

the first priority than it is of great statistical significance. Nonetheless, the President and the Congress are determined to use the law to prevent genetic discrimination, no matter the incidence. The Kennedy-Kassebaum bill 

in 1996 denied health insurers from discrimination based on genetic reasons when enrollees are moving from one

group plan to another. New legislation will be aimed to prevent such discrimination against those with individual

insurance.14 Predictably, each state and the Federal Government will legislate against such uses of genetic information. Perhaps impetus will be brought by such actions to universal health coverage, since the public will be more

aware that each person’s genes are different but that all persons are more or less susceptible to common diseases 

due to their inheritance.

The last priority may be one of the hardest to embrace because of its controversial nature, but it is 

necessary to close the largest gap of all in genetics, i.e., the one between diagnosis and treatment.

Confronting Controversial but Vital Research (e.g., human embryo (stem cells) and fetal research) 

for Understanding the Pathophysiology of Genetic Diseases and Bridging the Gap between Diagnosis 

and Treatment of Genetic Disorders by Gene Therapy and Other Treatments

My introductory point is one I know that Dr. Collins will affirm. Collectively, there should be more fear of and

action about the growing gap between diagnosis and treatment than about genetic discrimination. However, Congress and the President are going in the opposite direction, in my view, on controversial research policy vital to

closing this gap. I am speaking about embryo research and the tortured history of U.S. policy on fetal research.

Congress has banned any federal support of investigative human embryo research, even if the embryos are

“spares” that are not transferred after IVF procedures. Federal funds cannot be used for research in which a human

embryo may be “destroyed, discarded, or knowingly subjected to risk of injury or death.” The ban overrides a

majority view in the final report of an expert NIH Human Embryo Research Panel of 1994,15 which approved 

fertilizing ova for research purposes under certain conditions. The report was endorsed unanimously by the 

Advisory Committee to the Director of NIH, Dr. Harold Varmus. A few hours later, President Clinton issued 

a statement announcing that he did “not believe that federal funds should be used to support the creation 

of human embryos for research purposes,”16 and that he had directed NIH not to support such research. It 

is likely that Mr. Clinton, not unlike many thoughtful persons, opposed creation of embryos for research on 

the basis of a moral intuition that it is simply wrong to do so. Such a position was taken in an editorial in the

Washington Post17 in early October of that year. It alerted the Administration to embryo research prior to the 

1994 elections. It criticized the recommendation of the Panel to permit fertilizing ova for research only. The 

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writer was “deeply alarmed by . . . scientists purposely causing conceptions entirely divorced from the purpose 

of reproduction.” The writer, like President Clinton in his statement, gave no attention whatsoever to the scientific

and clinical losses in forgoing this option. Possibly, the Post editorialist and President Clinton would respond differently if there was more evidence assembled as to the benefits. The NIH Human Embryo Research Panel report lists

thirteen areas of knowledge with clinical benefits ranging from immediate to long range. Each one directly affects

women’s health.

Providing Basic Knowledge about Normal Early Human Development

A serious collision has occurred between progress in the federally funded Human Genome Project, the hope 

of treating genetic disorders, and the barriers to federal support of embryo and fetal research. The basic social

problem with the Human Genome Project is that the power to diagnose is disproportionate to the power to treat

genetic diseases. The power to diagnose virtually every genetic disorder in utero and after birth is vastly eclipsing

the power to treat. Abortion or voluntary sterilization are the two major ways to prevent genetic disease. Blocking

embryo research prevents several alternatives to selective abortion as a means of prevention. It is essentially cruel

and unfair to parents at higher genetic risk for Congress to block progress in embryo research and reduce the

chances of using two options to avoid genetic risks: 1) preimplantation genetic diagnosis and 2) early embryo 

or fetal therapy. How can in utero gene therapy succeed without embryo research?

Basic studies of pathophysiology and gene expression in embryos are clearly needed for human gene therapy,

whether attempted in utero or in the living child or adult. The present effect of the stalemate in the United States 

on embryo research is to infringe on scientific freedom even to study the pathogenesis of genetic diseases in the

human embryo. NIH’s role in embryo research ought to flow from this imperativeness. There are sound internal 

reasons for doing so. Stuart Orkin and Arno Motulsky were commissioned by the Director, NIH, to report on 

NIH’s investment in human gene therapy. Their 1995 report18 strongly recommended basic studies of pathogenesis and pathophysiology of genetic disorders. Such studies must eventually be done in the embryos of couples

at higher risk for genetic disorders, in order to understand the molecular onset of such disorders. It is important 

that the public and Congress understand why “spare” embryos will not provide answers to these questions. President Clinton, unlike Congress, favors research with unused “spare” embryos if donated voluntarily for research by 

a couple in treatment for infertility by IVF. However, “spare” embryos will not answer questions about genomic

imprinting or gene expression for specific diseases. Specific embryos from couples at higher genetic risk must 

be recruited for such research. NIH has funded no embryo research in light of the Congressional ban.

This public policy and the search for sounder scientific foundations for human gene therapy have already 

collided, but it is doubtful that the American public or Congress is truly aware of the consequences. This situation

also defeats the sound science already required as NIH funds experiments in human gene therapy and anticipates

funding of in utero stem cell transplants or fetal gene therapy. Do we know the natural history of any genetic 

disease if we are ignorant of how it begins or if it begins in the embryo? If our scientific knowledge is incomplete, 

our ability to do therapy is thereby limited, as long as we do not violate significant ethical principles or norms 

in carrying out scientific studies. I appeal to Dr. Collins and to other NIH leaders to make the need for embryo

research known to Congress and to take the lead in educating the nation on the issues.

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References

1 Bureau of the Census, Bennefield R. Health insurance coverage 1996. Current population reports. Series P-60. No. 199. 

Washington, D.C.: Government Printing Office, 1997.

2 Newacheck PW, et al. Health insurance and access to primary care for children. N Engl J Med 1998;338:513-9.

3 Budetti PP. Health insurance for children — a model for incremental health reform. N Engl J Med 1998;338:541-2.

4 Clancy CM, Brody H. Managed care: Jekyll or Hyde? J Am Med Asso 1995;273:338-9.

5 Kassirer JP. Managed care and the morality of the marketplace, N Engl J Med 1995;333:50-52.

6 Reinhardt U. Wanted: a clearly articulated social ethic for American health care. JAMA 1997;278:1446-7.

7 Jacobs LR. Politics of America’s supply state. Health Affairs 1995;14:143-57.

8 Iglehart JK. From the editor. Health Affairs 1995; 14:5-6.

9 Blendon RJ, Brodie M, Benson J. What happened to support for the Clinton plan? Health Affairs 1995;14:7-23.

10 National Institutes of Health Revitalization Act of 1993 (Public Law 103-43), June 10, 1993. 

11 Billings PR, et al. Am J Hum Gen 1992;50:47679.

12 Lapham EV, et al. Genetic discrimination: perspectives of consumers. Science 1996;274:621-3.

13 Wertz, D. 1997.

14 Weiss R. Clinton to support legislation guarding against gene-test bias. Washington Post, June 14, 1997, A8.

15 National Institutes of Health. Final Report of the Human Embryo Research Panel, September 27, 1994.

16 Marshall E. Human embryo research. Clinton rules out some studies. Science 1994;266:1634-1635.

17 Washington Post. Embryo research: drawing the line. Editorial, October 2, 1994, A 21.

18 Orkin SH, Motulsky, AG. Report and recommendations of the panel to assess the NIH investment in research 

on gene therapy. National Institutes of Health, Dec. 7, 1995.

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Robert F. Murray, M.D.

Chief, Division of Medical Genetics 

Professor, Pediatrics, Medicine and Genetics

LEGAL AND ETHICAL ISSUES* Howard University

We must make a distinction between screening and testing. The term “testing” in genetics is often 

used to cover both issues. For ethical reasons, however, we should recognize that testing is done in 

a clinic, for a family with a reason or, in some cases, an age-related reason for doing the evaluation. 

The patients are assured of getting either a positive or negative result and receive some information about the

importance of the tests. With screening, however, individuals are tested without any prior reason for wanting 

the testing. Ethically, informed consent becomes an important issue and a critical part of the process. 

In 1975, a National Academy of Sciences Committee, and in 1995, an Institute of Medicine Committee, 

determined four reasons for genetic screening: management of disease, reproductive information, to prevent 

a disease that has an effective treatment, and to conduct research. 

A genetic task force at the Hastings Center developed guidelines for setting up a screening program. When 

one is considering setting up a screening program, I recommend following these guidelines. Members of the community should play a role in setting up the program, that is, women in general, not just women who are highly

educated or especially interested. Representatives of all groups should be involved. Informed consent should be 

a critical part of any program. The diagnosis of the screened-for disease must be accurate and unambiguous. For

example, the diagnosis for cystic fibrosis (CF) is ambiguous because some 15 percent of people will not be certain 

if they get a negative test result whether they, in fact, have a gene that has not yet been identified. The test is 

much better than it used to be, but it is still, by some criteria, not acceptable.

Professional genetic counseling is a critical part of any medical or genetic screening program. We have a shortage of genetic counselors. If we were to start nationwide breast cancer screening or CF screening, we would have 

a problem getting well-trained people to do the proper counseling. Test results should be kept confidential.

I think that the biggest problem in genetic testing of women is stigmatization. When you are labeled as 

having a mutant gene, whether it is a disease gene, a disease susceptibility gene, or just being a carrier for a 

gene, you have a mark. People often tend to lie about their genetic status. In screening an entire village to reduce 

the frequency of sickle cell disease, researchers found that counseling people not to have children with a man or

woman who had the same sickle cell gene had no effect whatsoever because the people simply lied about their

genetic status. The people understood perfectly well what that meant, but if they fell in love with somebody, 

the rules changed. Of course, we know human behavior is very unpredictable.

Genetic testing raises the specter of stigmatization. One program, Tay-Sachs testing, followed the guidelines 

on ethical and legal issues suggested by the Hastings Task Force, and sickle cell testing program did not. The 

sickle cell test was a disaster. It produced all kinds of problems that took years to remedy. The Tay-Sachs program,

however, has been a resounding success, so much so that we are now seeing Tay-Sachs disease predominantly 

in populations of non-Jewish individuals rather than among Jewish populations.

* Presentation edited from the meeting transcript. 

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HEART DISEASE RESEARCH IN WOMEN: Claude Lenfant, M.D.

A LOOK BACK AND A VIEW TO THE FUTURE Director, National Heart, Lung, and Blood Institute

Whenever the subject of women’s health issues comes up, heart disease is one of the first topics. 

In a way it should be, considering, it is likely that one-third of women will die from heart disease. 

For nearly a century, heart disease has been the leading cause of death in women.

There is a widespread perception that the research has not done the best it could by women, particularly 

in the area of heart disease. The National Hearth, Lung, and Blood Institute is celebrating its 50th anniversary, 

so I hope you will all come up with exciting recommendations for the next half century of our existence.

Two recurring questions have been raised about our historical efforts: Has research on heart disease neglected

women? Has research on heart disease benefitted women? With regard to the first question, there are two answers,

but I would like to provide some evidence that no should be given greater weight.

The National Heart, Lung, and Blood Institute was founded in 1948 when the most pressing health issue was

the soaring death rate from heart disease. There was some increase in cancer and stroke, but certainly not to the

extent of what we saw for heart disease. As a consequence, the Framingham Heart Study was launched, which is 

a project of the National Heart, Lung, and Blood Institute. It was, in effect, the first major population-based study

of heart disease in the United States and probably in the whole world. From its inception, the study included even

more women than men, and although it is 50 years old, it has contributed enormously to our understanding of 

the causes of heart disease in both women and men.

In the early years of the study, however, most of the information we gleaned about heart disease and risk were

more pertinent to men because women in the middle-age cohort were not developing heart disease at anything

near the rate of men. It would be number of years before enough cases occurred in women for us to make a connection between risk factors and disease.

As we came to the end of the second decade of operation, we had enough information to undertake clinical

trials of promising interventions to prevent and treat heart disease. I want to spend a bit of time on the subject

because concerns about the systemic exclusion of women in all clinical trials have been expressed repeatedly.

The Institute launched its first clinical trial in 1965, and since then reported 59 major clinical trials of cardiovascular disease in adults (major means a population of at least 400). Forty-one of these clinical trials included

both men and women, four included only men, and 14 included only women. This looks like a reasonable track

record when it comes to interest in women, but the skeptics might argue that the large number of trials conducted exclusively in women represents a recent attempt to play catch-up. In fact, that is true — all 14 trials 

were started within the past 10 years.

So let us turn to the earlier clinical trials and, specifically, to the four that did not include any women. Our

very first clinical trial, the Coronary Drug Project, which was initiated in 1965, was a very interesting trial for two

reasons: it attempted to reduce coronary risk in men by administering among other things, estrogen; and it was a

failure. This put a very serious damper on clinical trials for the next few years. In fact, it took 6 years for the next

clinical trial to be initiated. The very successful Hypertension Detention and Follow-up Program was launched and

included 11,000 subjects, of whom more than 5,000 were women. Since then we have conducted an additional 

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11 major clinical trials on the treatment and prevention of hypertension, all of which have included a substantial

number of women. The latest in this long series of clinical trials is the Antihypertension and Lipid-lowering 

Treatments to Prevent Heart Attack trials, which is recruiting 18,000 women from a total of 40,000 patients. 

Following the HDFP, three major trials focused exclusively on men: the Multiple Risk Factor Intervention 

Trial (MRFIT), the Lipid Research Clinics Coronary Primary Prevention Trial (CPPT), and then the Physician

Health Study. How and why does that happen? Why were women excluded?

There are two reasons for focusing research on one population group to the exclusion of another. The first 

one is public health concerns and the other one is pragmatic considerations. Both MRFIT and CPPT fall in the 

first category. At the time of their inception, the heart disease epidemic was at its peak (1972-1973), and the segment of the population most affected by this epidemic were men. Overall, heart disease death rates in men and

women were not too dissimilar during the first two decades of the century, but from the 1920s onward rates 

in men soared.

In particular, the devastating effect of coronary heart disease on men in their prime working years was viewed

as a national emergency. In 1973, about four out of five deaths that occurred in people under age 55, and three out 

of four deaths in people age 55 to 64, were in men. Basically, at that time the major burden of premature deaths

from chronic heart disease was really in men, and this burden is still borne by men. The Reader’s Digest article 

from 1967 described the problems of a 45-year-old Joe but never mentioned that Josephine had a heart too. The

message for middle-aged men was clear. Coronary heart disease is going to kill you. The message to women at 

that time was that coronary heart disease can make you a widow, and health-related counseling was focused on

how to avoid that fate. Our initial attempts to reduce risk of premature coronary heart disease focused on the 

population most at risk, middle-aged men. 

Another reason for focusing trials on a particular group are pragmatic considerations with respect to the 

feasibility, cost, and timing of the trial. A case in point is the Physicians’ Health Study that began in 1981, and 

it enrolled more than 22,000 healthy physicians age 40 to 84 years. The study population was chosen because 

it was thought that physicians would be cooperative, compliant, reliable subjects, capable of providing accurate

information about health studies. Because of the insufficient number of women physicians in the United States 

at that time, and the lower incidence of coronary events in women, the study was designed to include only men. 

It should be noted that to provide a study population with a sufficient number, 261,248 men had to be screened.

Had it been performed in women, the number of screenings would have had to have been much larger, probably

four times as large. 

In fact, if you look at the Women’s Health Study that we began in 1991, the number of women screened was

1.7 million women health professionals and 39,876 enrolled. The same pragmatic considerations about the feasibility, cost, and timing of clinical trials still apply today and are reflected in the many studies of hormone replacement therapy to prevent health disease in postmenopausal women. Such considerations have a particular influence 

on the choice of endpoints to be measured. 

For example, the PEPI trial, initiated in 1987, sought to determine the influence of hormone replacement therapy on coronary heart disease risk factors, rather than on clinical coronary events. Given this choice of endpoints, 

it was possible to do the study in a cohort of only 875 women and also to answer this question in a short period 

of time (followup was only 3 years). The results, published in 1995, have provided very valuable information to

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women and their physicians who must make decisions today about whether or not to use hormone replacement

therapy. However, they cannot tell us whether demonstrated improvements in risk factors will actually translate

into an improvement in risk of a coronary event.

At the opposite side of the spectrum is the Women’s Health Initiative, begun in 1991 and recently transferred 

to the National Heart, Lung, and Blood Institute. Its trials are designed to look at clinical coronary endpoints — 

for example, heart attack, death — and provide a definitive answer on whether hormone replacement therapy 

does, in fact, make for a healthier heart. Unfortunately, such an answer comes at a very high price. The Women’s

Health Initiative will have to recruit 64,500 women and follow them for as much as 12 years, with no results 

really coming through until a few years into the next century.

However, let me assure you that we are not just sitting by waiting for the Women’s Health Initiative to come

up with its results. We have a number of clinical trials under way using angiographic measurements of the coronary arteries to determine the effect of hormone replacement therapy on coronary disease, sometimes in combination with other approaches such as antioxidant vitamins or lipid-lowering drugs. With this approach, it is

unnecessary to include a large number of women for an extended period of time.

I hope that the foregoing information has shed light on our history of including women in studies of heart 

disease. In the past we have taken advantage of many opportunities to do so, but we have also missed some 

opportunities for reasons that made sense at the time but admittedly may not seem persuasive to you. But 

today I believe we are moving forward with commitment, purpose, and speed to address these issues.

Against this backdrop, let me turn briefly to our second question: Has our research on heart disease research

benefited women? Once again I will give two answers — a big yes and a cautionary no. The decline that we have

witnessed in heart disease has been spectacular both in men and in women, but what the rate today is in men 

is the same that it was at the beginning of the century. In contrast, the rate for women is much lower, actually 

37 percent lower than it was in 1900.

The longevity for both men and women increased quite remarkably in this country. In fact, between the years

1965 and 1993, we can attribute the increase in life expectancy to a 44 percent decline in coronary heart disease 

in both men and women; 16 percent of this increasing longevity is due to the decrease in death rate from stroke.

In looking at this, we can demonstrate that about 60 percent of the increasing longevity that we have seen in this

country during the last 30 years is due to a decline in the death rate from cardiovascular disease. With regard to

change in coronary heart disease death rates, when we began many of the clinical trials we mentioned above, you

can see that these rates have declined remarkably, particularly in the younger age groups and that men and women

have benefited from this trend to approximately the same extent.

My cautionary note stems from the observation that while calling for an ever increasing share of research

attention, women are not taking full advantage of heart-saving information that we already posses. Risk factors 

for heart disease in women have been known for years, and we made an effort to educate the public about them.

However, the current prevalence is higher actually in some cases than in men, such as for women with obesity 

and a lack of physical activities. 

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Our enormously popular Healthy Heart Handbook for Women has appeared in three different versions over 

the last 10 years, but its message that heart disease is every women’s concern has not yet captured the attention 

of women. Indeed regarding perception and reactions of women in the face of heart disease, the results of a survey

published in USA Today revealed quite clearly that women’s perception of heart disease as a health risk far 

underestimates the true risk. My point is that we can put millions of dollars into research, but the yield will 

be low if women and their physicians fail to use the knowledge to improve their health.

In the area of hypertension our record of including women in critical trials has been impeccable, and we 

continue to generate new evidence of the benefits of hypertension control, especially in the elderly. Data from 

the Systolic Hypertension in the Elderly Trial, which included 1,359 women and analyzed its findings for women 

and men separately, clearly illustrate that treatment of isolated systolic hypertension greatly reduces the risk of

heart failure. We are focusing particular attention on women because they constitute 61 percent of the 24 million

Americans over the age of 70. 

To this end we have joined forces with the Alliance on Aging in a campaign that is called “Controlling High

Blood Pressure in Older Women, You Have What it Takes.” Indeed, that is exclusively under the control of women.

We know what to do; the physician knows what to do. The issue is whether women are going to take advantage 

of what we know. In individuals who have a relatively normal blood cholesterol, there is a decrease in the risk 

of clinical events of 54 percent in women as compared to 34 percent in men.

Our 50th anniversary logo represents people doing science to improve the health of people. By that we 

mean all people, and I can assure you that we will carry this philosophy with us into the future. My last 

thought is this: “There is more future ahead of us than past behind us.” 

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Julie Buring, Sc.D.

RESEARCH ON WOMEN: Associate Professor of Ambulatory Care and Prevention

AN INVESTIGATOR’S VIEW Harvard Medical School

We all know that the need for a continued and expanded commitment to a broad range of research

issues in women is ever more important and timely. However, as investigators, I think it is important

for us to also remember that we are increasingly coming to know very deeply that the need for more

research in women on an ever expanding agenda of issues is urgent. Regardless of the specific issues that we are

interested in and that we are doing research on, the planning and the conduct of such studies must always be 

driven by the commitment of providing to women the fruits of the best high quality science that can be done 

to answer the question.

Research on women’s health requires well-designed studies of sufficient sample size to answer important and

timely questions in women definitively. These investigations in women without question are likely to have unique

and important scientific and logistic problems that are different from doing trials or studies in men. These simply

have got to be recognized and addressed by whatever means it is possible for us to develop. The real bottom line 

is that what we want to do, the goal of all of the studies that we do or that we think are important, is to provide

either a definitive, positive result on which individual clinical decisions and public health recommendations can be

reliably based or provide us with a reliable, definitive no result, which will allow resources to be safely redirected

into other promising areas of research. We owe not just research to women, but the clarity of an answer to women 

as well as to the community.

The fact is that the underlying goal of all of our research has to be to provide an answer. In many situations, 

it has been suggested or it is logistically easier to simply add a few women into a study. The numbers have not

been calculated to be sufficient to add important information to the totality of evidence on the scientific question 

in women, but rather to just include women. The intent may be good, but this unfortunately can and has led 

to misleading conclusions on scientific questions in women and could set us back in terms of our knowledge.

Some of my research has related to evaluating the role of low dose aspirin in the primary prevention of cardiovascular disease and cancer in healthy women as well as men. In cardiovascular disease, our clinical trial was to

answer the question in healthy women, which represented the last step in a process where the role of aspirin 

has been appropriately evaluated first in women who have a history of cardiovascular disease. In the early 1980s, 

if you looked at the Food and Drug Administration’s prescription labeling or professional labeling of aspirin, it

approved labeling indications for aspirin for patients, men and women, with a prior heart attack; patients, men 

and women, who have unstable angina or chest pain; and men with a history of transient ischemic attacks (TIAs),

which are the pre-strokes of short duration. The problem is that if you look at a recent Physician’s Desk Reference, 

it will say that aspirin works to prevent TIAs in men, but it does not work to prevent TIAs in women.

When you actually went and you looked at the data, you saw something very different. In fact, this was the 

study on which it was based, the Canadian study of TIAs. In men there was quite a clear benefit of 47 percent,

which was statistically significant, but there were 406 men and 179 women in the trial. We had a relative risk 

that was not indicative of benefit and was not statistically significant, but the thing that we all look at first is 

the confidence interval, which clearly showed that these data were compatible with the benefit, but could not

demonstrate a benefit due to the small size.

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Over the last few years we have formed an aspirin strategy group, which has worked with the investigators 

in Oxford, England, to look at the entire world literature on this question. Seventeen years after FDA first made

their ruling, it has been changed. In 1997, the advisory committees to FDA have voted to approve expansion of 

the professional labeling for aspirin to include women as well as men with prior TIAs. For 17 years, we were 

under the belief that it did not work in women, whereas the true interpretation of the data was that there had 

not been sufficient numbers of women for us to answer that question definitively.

In 1982, the Physician’s Health Study wanted to answer a very simple question. If we take an aspirin tablet

every other day, will it reduce our risk of having our first heart attack? We wanted to do it in a very cost-effective

way because we knew the sample size would be very large. We wanted to do this study entirely by mail, and we

would, in fact, never see the participants in the trial. Thus, we wanted to do it in health professionals, and in particular, we chose to do it in physicians because they would be aware of possible side effects and be able to give 

us their health history with a high degree of confidence.

When we went to design the study, we had no intention of doing it in men, but we wanted to do it in physicians. However, only 1 out of every 10 physicians over the age of 40 in the United States was a women in 1982.

Women have lower risks of heart disease than men at the same age. Therefore, we calculated they would have onethird the number of coronary events by the age of 60, as the same size sample of men. When we looked at what

participants were available to us, we would have been able to randomize 22,000 men and 2,200 women, whose

event rate would have only been a fraction of that in men. If we did not have enough women in the study, we

would never be able to test the hypothesis that aspirin was effective in the primary prevention of cardiovascular 

disease in women. We would never be able to evaluate the question, is the effect of aspirin on cardiovascular 

disease different for men and for women?

We put the grant into NIH, and the Review Committee said to put the 2,200 women in the study. What we

did was actually go back to NIH and say we really wanted to talk to them about this because we really envisioned 

a very important thing happening. In particular, at the end of the study, if we did see a benefit in men, then we

would know what to recommend, but if we saw no statistical benefit in women, nobody was going to know

whether it was not there because we did not have the power to do it or because it does not work the same in

women. We wanted to do two trials, one in a sufficient number of women and one in a sufficient number of men. 

Dr. Claude Lenfant, the National Cancer Institute, and NIH supported us in this and, in particular, funded 

us to do the Women’s Health Study (on which I am a principal investigator), which is looking at the benefits and 

risks of low dose aspirin and vitamin E for the primary prevention of cardiovascular disease and cancer among

40,000 U.S. female health professionals. This is a trial done by academics, funded by NIH, and supported by 

the drug companies that are providing the drugs to us. 

We sent letters to 1.7 million U.S. female health professionals throughout the United States, and 453,000 

of them returned a questionnaire to us. We have 39,876 randomized into the trial with 79 percent of them with 

at least 3 years of followup and with 70 percent of them having provided, by mail again, a blood specimen so 

that we have the opportunity to bank it as a future resource. This is a wide variety of female health professionals

from dentists to dieticians to nurses, physical therapists, physicians, veterinarians; a whole host of people who

allow us to have a very diverse group in the study.

It was important to note that the study in men required a sample size of 20,000 men over the age of 40 

and the analogous study in women required 40,000 over the age of 45 because women have a lower risk of heart 

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disease. The cost was the same, $80 per participant per year, but the total cost of the Women’s Health Study 

was much more because of the increased the sample size.

It may be that lower numbers of events for women for many outcomes of interest, such as cardiovascular 

disease, require that the trials will have a bigger sample size and thus a bigger cost. Some trials will have more

logistical difficulties to overcome. However, if they are well designed and conducted, they will allow us to get

direct inferences in women, rather than generalizing from research in men. We will be able to make clinical 

recommendations for women from women. 

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY
Richard Klausner, M.D.

THE CANCER PROGRAM AT THE END OF THE 20th CENTURY* Director, National Cancer Institute

I

wanted to give you a brief slice into our vision of where we are in our struggle against cancer as we end this

century, a century of remarkable discovery. Some real progress has been made, but we continue to have great

frustration with the enormous burden of these diseases. A remarkable thing has happened in the science of

studying cancer, and that is as we end the 20th century, many years, decades, centuries of wondering and arguing

about the nature of cancer is reaching some critical level of resolution. We know what cancer is. Cancer is a genetic

disease generally, not an inherited disease, but a genetic disease. 

We know that all cancers arise extremely gradually. The moment of diagnosis is an extraordinary event in 

an individual’s life, but it is in some ways a random moment interposed upon an extremely long process. It is 

a process whereby one of the hundreds of trillions of cells within the human body that we have throughout our

lifetime has accumulated a set of changes or instructions that determines the behavior of the genes. That is why 

it is, we know it to be, a genetic disease.

It results in the misbehavior of cells, which we clinically call cancer. It is a result of an accumulation over 

years to decades of probably small — although we still do not know the exact number — critical changes in the

instructions that guide the behavior of cells. That is why they misbehave. Now, that simple statement is important and defines our central hunt in cancer biology. It will define profound alterations in our approaches to 

preventing, to detecting, to finally correctly diagnosing these diseases and determining treatment.

Why is that? If we knew how to read and interpret the altered instructions and the altered machinery that 

those instructions direct, we believe we would be able to move from a period of extraordinarily and remarkably 

successful, highly practiced therapeutic empiricism to a new period of design and predictability. This is very 

much the way we looked into the blueprint of HIV, saw a machine, and pretty rapidly were able to design 

something directed not towards the phenomenology of a viral infection but to its precise machinery. It is not 

the answer, but it is a real step in the right direction. 

Knowing that there are a set of genetic changes that define the behavior and the development of any cancer

and with the ability to read and interpret all of those changes opens up the possibility of removing an enormous

amount of the mystery of these diseases and to finally think about designing interventions that will define cancer

therapies in the future. The gradual accumulation of changes tells us something about the problematic definition 

of these diseases. 

When does cancer begin? When do we call it a disease? When do we treat it? We know that these diseases

emerge from decades of changes, of states that are precancer. Pathologists have been looking at some of these

changes. These precancerous changes represent cells that have accumulated some but not all of the altered instructions that ultimately result in a clinically diagnosed disease. The ability to read again and to detect those earlier

changes provide a new way to think about prevention, to think about cancer as a process and not an event, to 

recognize that if cancer emerges over decades with partial changes, those alterations ought to be the diseases 

we learn or the pre-diseases that we learn to intervene. 

* Presentation edited from the meeting transcript.

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There is, in fact, a continuum of treating the initial change to intermediate changes we need to learn and 

to direct our attention more and more on not treating cancer but precancer. The line between prevention and 

treatment will get dramatically blurred over the next few years. We need to make sure that artificial distinctions

defined by where you get funded or how you identify yourself do not drive our view of the world. What drives 

our view of the world is the disease and the individuals who are susceptible and who have these diseases.

Our ability to identify cancer allows us new opportunities in early detection. Most of our early detection is

based upon waiting until there are enormous numbers of cancer cells so that we can see a physical mass or that 

we can see the effect eroding into a blood vessel. There really is the possibility that we now know how to systematically search for all possible molecular markers and to ask the question once and for all, are there valid markers 

for the development, progression, and existence of cancer. 

This begins with the cancer cell and our knowledge about the cancer cell. We want to understand, of course,

what causes cancer. We can begin to see the progression of changes in a cell, the multiple inputs that determine

the likeliness that there are changes in our DNA, and the likeliness that we allow those changes to survive in the

population of cells. This is where we begin to get a sense for external and modifiable inputs in effectors of cancer.

We know that the vast majority of cancers are due to potentially modifiable external factors; we know that

from epidemiology, from migration studies, etc. However, identifying those factors is quite difficult. The causes of

these changes in our genetic instructions that accumulate in the life of a cell and will become cancer include in a

small percentage of cases an inherited defect, an inherited alteration. What those alterations are represent the fact

that some fraction of individuals are born with one of those changes that are going to have to be accumulated in

anyone that gets cancer. So the need to probablistically accumulate 5, 10, or 15 changes is altered because an 

individual already starts with one of those changes, giving them a predisposition. 

I emphasize that there is no such thing as a cancer gene. Our language is all wrong, and it is dangerous. We

talk about ethnic genes, which is a disaster. We talk about cancer genes when what we are talking about is identifying a gene whose normal function is to protect us from cancer. We need to be careful as we move into this genetic

age that we understand genetics and use language carefully that communicates correctly the issue of risks and not

predeterminism. We have the opportunity with genetics once and for all to end the misconceptions about the

genetic bases of race and ethnicity that drive so much that has been misused throughout history, if we use our 

language carefully and our concepts correctly.

Cancer genetics is inherited differences between people that alter their risk of cancer. It does not mean people are

predetermined to get cancer, and it does not mean that those with altered risk are not, in themselves, profoundly

modifiable. There are other causes of cancer, infectious causes. Only in the last 10 years have we identified a virus,

a group of viruses, that cause one of the most common cancers in women in the world and that is cervical cancer.

Human papilloma virus and a series of subtypes we now know are the cause of at least 90 percent of cervical cancer. Knowing that is incredibly important. It allows us to modify our approach to what may be overarching detection, that is the Pap smear, where we recognize abnormalities, but we do not know which of those abnormalities

are going to lead to cancer. This is a problem with mammography. It is a problem with PSA. We need to be able to

not only have sensitive detection but detections that we can interpret what we are detecting, that they are predictive.

Knowing that certain subtypes of human papilloma virus cause cervical cancer will help us make decisions

about how to treat women with abnormalities on Pap smears. Perhaps more importantly, we are moving quickly 

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to try to create a vaccine against a collection of these subtypes, and we hope that within 6 years, we will move

through NCI-sponsored phase 3 trials of polyvalent vaccines, the first vaccine specifically developed to prevent 

cancer. Actually, the hepatitis vaccine also prevents cancer, but it was not developed for that. This is an extremely

important program, especially for the developing world.

We assume carcinogens cause many of the changes. What are carcinogens? They range anywhere from oxygen

to iron that we all need, to contaminants from the environment, to tobacco smoke. They work through the crucible

of these genes. They work because they alter genes and for the likeliness that genetic alterations are corrected. We

must remember that every time a cell divides, it has to copy three billion different bases of DNA in several hours;

that copying machine, which is spectacular, makes a few hundred mistakes every time. So, it is 99.9999 percent

good, which is incredibly good, but it is not perfect. The fundamental aspects of life itself predispose us to cancer,

but it is dramatically changed by exposure to environmental factors that damage DNA, directly or indirectly.

Modifying whether an altered cell becomes a cancer is an extremely important part of understanding cancer

risks. Diet, which may include carcinogens and anti-carcinogens, may modify whether an altered cell grows and 

is able to develop into a cancer. There is no question that hormones play a central role in the risk for and development of important cancers, especially breast and reproductive cancers. This is going to be an area of extraordinary

complexity and challenge. Estrogens present powerful modulators that beckon us to the possibility of effective

interventions and preventions but raise issues that are fought with enormous complexity.

Estrogens represent complex collections of compounds, and they work through at least two receptors, each of

which are modulated by a collection of genes that only now are being identified. We know that suddenly altering

the estrogen molecule can produce dramatic changes in the effects of the estrogen. This complexity of estrogen

biology raises the possibility of the ability to design extremely specific estrogen response modifiers, but what if we

find that specific anti-estrogens reduce, possibly dramatically, the risk for example of breast cancer? How are we

going to deal with that? Who in our society perceives themselves to be at increased risk of breast cancer? What

level of increased risk results in recommendations or decisions by healthy women to intervene in hormonal pathways? What is an acceptable risk? How should a woman go about determining and evaluating that? 

Clearly the benefits of an intervention must be weighed versus the risk. It is clear that with this new understanding of estrogen biology, the ability to at least modulate risks by more precise design of these interventions 

is possible. However, the challenge of hormonal manipulation of healthy individuals to reduce the probability 

of disease is something we are going to be struggling with over the next several years.

Other areas such as exercise, I do not have time to comment on. All of the factors that I have talked to you

about, carcinogens, genetic susceptibilities, viruses, hormones, diet, are themselves filtered through other genes

that determine individual variation, how they metabolize hormones, metabolize carcinogens, repair DNA, and on

and on. We are only beginning to get a glimpse at how we are going to rethink the area of genetics, not by thinking about these rare and Mendelian inherited or high penetrance predisposition genes, but, in fact, it is the enormous variability of each one carrying about three million variations.

There is overwhelmingly more variation between individuals, other than identical twins, within any historically, culturally, sociologically, or superficially defined ethnic or racial group than there are between any groups 

in the entire human population. It is these subtle variations that will be the nature of cancer genetics. 

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It is important because we struggle and will continue to struggle to identify causes of disease, causes of cancer. We use epidemiology, but epidemiology gives us associations, often misleading associations, often interesting

surrogates for real associations. It does not give us cause and effect. It is knowing cause and effect that allows us 

to predictably go back and alter risks. We hope that the marriage of classic epidemiology with understanding variations among individuals in terms of their interaction with their environment at large, behavior, etc., and the ability

to use, especially in cancer, these genetic changes as a type of environmental dosimetry will hopefully clarify some 

of the elusive environmental, hormonal, behavioral causes of cancer.

How we are going to go about capturing all of this information is an enormous challenge. Cancer is an 

enormous puzzle. We are trying to put together a jigsaw puzzle, not knowing how many pieces are missing, 

not knowing how important the pieces are that we have, not knowing how important the pieces are that we 

are missing. In terms of the biologic pieces of cancer, we now know we ought to be able to get all of them, 

once and for all, to make sure we are playing with a full deck. 

We have established an infrastructure called the Cancer Genome Anatomy Project, which is a web-based 

discovery structure, whose goal it is within the next few years to attempt to discover all genes that are expressed 

and altered between normal cells, premalignant cells, and malignant cells. We have finished moving through

prostate cancer. We are now doing breast cancer, and for the first time, we are getting a complete description 

of all of the genes expressed in breast epithelial cells, in ductal epithelial cells, premalignant lesions, and malignancies. Our goal is to do one to two million sequences. It immediately goes onto a public database and provides 

a means of discovery.

As we do this, we begin to get hints at identifying the molecular tags that actually characterize tumors. From

prostate, where we have been sequencing through normal prostate epithelium, something that had never been

done before, we can then ask the question do we see any genes that are only expressed in malignancy. It turns 

out the answer is yes, and we see that the first line that is expressed in normal premalignant and less so in malignant is prostate-specific antigen. That is what is used as a screening test for prostate cancer, and it is not specific

for prostate cancer at all. However, in this genome anatomy project, we are beginning to discover genes that 

appear to be only expressed as a function of the abnormal behavior of cells.

We know that we have been incorrectly diagnosing cancer. Children with neuroblastoma, when you treat 

these children the same, about 60 percent of them survive and actually are cured. Sixty percent — we accept that 

in oncology. We accept the stochastic nature of the roll of the dice of life, but it is not true because we are treating

different diseases. These are distinct molecular diseases. They look the same under the microscope, but we should 

no more expect cancer to be defined by what it looks like under the microscope. 

In early breast cancer, we know that some fraction of women with early breast cancer will recur regardless of

the treatment, but who? We will have to see if it holds up when we look at some molecular markers, and we see 

in these molecular markers that women by all other criteria we predicted the same outcome. We can see a dramatically different outcome for women with a certain molecular type of breast cancer versus the other. Modern

medicine is based upon correct diagnosis. If we cannot correctly diagnose a disease, we are not going to correctly

choose treatments. 

Cancer, in terms of its relative toll on the population, has grown. In 1973, about 17 percent of deaths were 

due to cancer. In 1994, it was up to about 23 or 24 percent. 

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How are we doing? Are we making any progress? Mortality rates do appear to finally be falling. Sometime

around 1990, when we look at overall age-adjusted mortality, a figure that had been climbing throughout this 

century since the early 1930s when we started following these numbers finally appeared to peak and now 

is falling. It is falling at what appears to be a significant rate.

Of course, this is lumping all cancers together, and they are different diseases. In fact, to understand where 

we are going with cancer, we need to look at different diseases and in different individual populations. This overwhelmingly is the epidemic of cancer. For lung and bronchial cancer, we see the ravage of the epidemic of smoking,

first taken up by men and then by women. The increase in the mortality rate was enormous in a disease that was

rare in 1940. We have done not very well at treating lung cancer, a disease that we know as much about preventing it as any other disease. 

If we look at all other cancers through this time, we see about a 15 percent drop in the mortality rate. For 

all cancers in all people below the age of 65, there has been about a 25 percent drop in mortality rate over this

time, and the drop in the mortality rates are accelerating over the last 5 years.

If we look at the burden of cancer in women, approximately 20 percent, somewhat less, of women right now

will die of cancer. In all studies, women dramatically over estimate their risk of getting breast cancer and of dying

of breast cancer. This is not to minimize the importance of breast cancer, but it is very important because our perception of risk determines what we do. For women ages 35 to 55, cancer is the number one cause of death. About 

3 percent of women will eventually die with the current numbers of breast cancer. About 4 percent, current numbers, will eventually die of lung cancer.

We predict about 270,000 women will die of cancer in 1997. Fifty percent of those deaths will be due to

colon/rectal and lung cancer, 16 percent of those deaths from breast cancer, and 10 percent from other reproductive cancers. Right now the average 5-year survival of women diagnosed with cancer is between 60 and 65 percent

and significantly higher than for men. In men, there is a much larger differential between the survival of white and

African-American men than there is for the survival of women.

With all of the incremental interventions made over the past several decades, we are seeing an effect. The

change in the mortality rate among groups, and this is all people, men, women, white men, white women, black

men, black women, in every case mortality rates were growing between 1973 and 1990, and since then, for all 

of these groups mortality rates are dropping. 

One overwhelming trend is a dramatic increase in the deaths of women, especially older women, from lung

cancer. Breast cancer mortality rates are dropping, and they are dropping significantly. Overall, about 9 percent in

the last several years. For women below 50, a 12.5 percent decrease; women below 45, it is almost 15 percent; and

the latest numbers from 1995 show those trends continue. Finally, in 1994 and 1995, we see a drop of mortality

rates, not just among white women but also among African-American women. However, this epidemic of deaths

from lung cancer, especially in older women, is extremely dramatic.

There is some good news: we are making progress against many cancers, but it is incremental. We are only

going to capitalize on all the things, if we can do two things. If we can move our biomedical approach to this 

disease from empiricism to a much more specific knowledge. At the same time, we must do a much better job 

at incorporating our approach to modifying the risks for cancer in our approaches not just through understanding 

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the genes and our biomedical models but also our public health and especially behavioral models. NCI has created 

a new division that Barbara Reimer will be heading up to really try to create an extremely strong behavioral 

and public health approach to dealing with risk, with risk perception, with health communications.

Embedding our knowledge about the disease within our knowledge about people, behavior, our society, 

and the multiple cultures within them is the real challenge in making sure that the drop in mortality not only 

continues but accelerates. 

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY
Antonia C. Novello, M.D., M.P.H.

Former Surgeon General, Visiting Professor

WOMEN AND RESEARCH: QUO VADIS? Johns Hopkins University School of Hygiene and Public Health

More than anything I wanted to talk to you because you are a little bit like me, small enough to be 

personal but large enough to be powerful. Now, it has been said that there are five messages a woman

has to hear as she grows up: she is loved and special; she can do anything that she wants; she can

dream of greatness; she is able to take risks; and she is able to use creative aggression and still remain feminine.

The problem is that the world has only told us that we are loved and special. The message that I want you to 

get today is that we are here to tell the world that even if they forgot to tell me I can do anything I want, I can

dream of greatness, I can take risks, I am able to be assertive and still be feminine, because I happen to be a

woman, and I happen to be very, very good.

I can also tell you I believe that the measure of a leader is not always found on what he or she has done 

but on the measure of his or her character; basically, the kind of character that becomes apparent when the 

spotlight has been turned off, the applause has died down, and no one is there to give you credit. Friends, is 

that what we women to do day in and day out? Let’s tell the world that we absolutely have a lot of character.

We know that character and leadership are complicated words; however, they mean many things to many 

people. For us women, I hope that leadership is not merely a goal and character is not merely a word but a 

reality of life. I can tell you that you would not be here today if you did not feel that your life and mind are 

worth celebrating, that our careers and societal standings are worth preserving, and that we have to work 

for a better tomorrow.

In all of us I believe is the capacity of nurturing and of healing that so often conflicts with the harsher requirements posed by our professional ambitions. Today, like men, we are supposed to be married to the job, while

expected, as women, to be traditional wives and mothers and, in the interim, be accused by some of being bad

wives, bad mothers, while they are trying to be like men. How can we set the record straight to show that there 

are equally effective alternative feminine styles that need to be emulated?

As I look into this audience I am extremely impressed. I see strength, accumulated experience, and intelligence that, despite whatever the world thinks are obstacles for us, we will have no problem in the year 2000 

getting what we need. We women are not petitioning for charity. We are just insisting on our given rights, by our 

own merit and not just by political quotas. We can do it without being counted. We can do it on our own merit.

I do not subscribe to the narrow concept about biology being destiny. It has been in the news all the time, 

but women and men are totally different. Men tend to think only in terms of work-related goals, while women

tend to set goals having to do with others to the exclusion of their own needs. I believe in the process of restructuring our lives, of becoming an authentic person. We women must cease to think of ourselves as a collection 

of habits, jobs, and roles, and instead think of ourselves as perfectly imperfect.

I do not mean, of course, that one sex is better than another one. We need both. I do not know if our differences come from nature or nurture or a combination of both, but we need new ways of working and living

together that really take care of our respective strengths. For us, it means recognizing that women are very 

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good on intuitiveness, empathy, attention to details, tendency to solve problems through work, and, more than 

anything, team work, listening, and providing strength in the face of adversity. Of course, I know that you know

many men who have these qualities, but I also know that you know many women who lack them as well.

Experience tells me that women, most women from all cultures and from all social classes, have those characteristics in abundance, and life has no way by which to recognize them. I can tell you that happens very frequently 

at the workplace. On top of that, when we finally make it, the world tells us that we have been lucky.

For me, lucky means when preparation meets opportunity. Our luck is be based solely on our merit and 

reflect our true worth. It will go without saying that the harder you work, the luckier that you become.

I can tell you that today all the women are moving up the corporate ladder and are reaching positions of

senior responsibility in the academic world and in the corporate world. There are still only two women executives in the Fortune 500 and only seven women in the top 1,000 firms. After winning seat after seat in the 

1990s, I can tell you that women’s progress is trickling down as shown by the fact that although 84 percent 

of the Fortune 500s have a woman that is exactly what they have, a woman. For that, I can tell you that women

make up just under 11 percent of the Fortune 500’s 6,081 seats. I can also tell you that despite our greater number in this country — 137 million, 2 million more than men — professional women are still a minority group. 

Women in biomedical research have, in a sense, been immigrants in the men’s world. In 1994, medical 

schools graduated 15,555 doctors, of which 5,919, or 38 percent, were woman. In 1993 there were 15,108 

people graduated with doctoral degrees; 38 percent were women. 

Sadly, as you can see, academic medicine has a glass ceiling as well. For one, men achieve the rank of full 

professor in 12 years. Women achieve it in 20. Even worse, women are four times less likely to ever make full 

professor during their careers. In 1993, women in medical schools were 23 percent of the faculty while only 

13 percent were tenured in science faculty and 10 percent tenured in the clinical faculty. Likewise, today we 

find 51 percent of women at the assistant professor level, 20 percent at the associate, and 10 percent at the full

professor level. If that is not bad enough, only 1 percent of women are deans, 14 percent associate deans, and 

4 percent department chairs, not to mention only two executive vice presidents.

At NIH during the last decade, women have been 29 percent of the post-doctorals, but only 18 percent of

tenured scientists. When I look at the 1997 data on the NIH research grants data report, although they say it is

incomplete because 3 to 10 percent of people do not put their gender when they submit their grants, I can tell you

that from a total of 32,109 research grants in of all types, the number of female PIs ranged from 85 percent in the

National Institute of Nursing Research to 13.5 percent in the National Center for Research Resources, representing

an average of 21 percent female investigators submitting research grants to NIH and succeeding in getting awarded.

The 1993 data in the NIH extramural government program show that 16.4 percent of research grant dollars

went to women, compared to 10.2 percent in 1984. In dollar terms, that is exciting because it means that funding

for women tripled and for the men doubled it. The success rates for women were a few points higher than for 

men in first awards (28 vs. 26 percent), K awards (42 vs. 38 percent), area grants (29 vs. 23 percent), and small

research grants (25 vs. 21 percent). 

In 1997, the percentage of women trainee appointments was 47.5 percent compared to 1992 when it was 

45.5 percent, accounting for only an increase of 2 percent in the past few years. I ask you, is 2 percent enough 

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for 52 percent of the population of the United States? I say no, and I think we are tired of the status quo, and 

this needs to be changed. This is why meetings like this are extremely important.

Those of us who have gotten to the top have done so by sacrificing family relationships, personal time in 

favor of faxes, meetings, and, more than anything, difficult assignments. I know that despite the fact that we still

make only 74 cents to the dollar, we are close to 50 percent of the American work force. Our success throughout

our life has been based on consistently exceeding performance expectations, while making it look easy, not to 

mention adjusting our personal style so as not to threaten our male colleagues. 

The reality is that we are not supposed to be attractive, smart, assertive, or even sexy. We must pretend we 

are not mothers, we are not married or worse, we pretend we are not having marital problems. Instead, right smack

in the middle of the year 2000, we must continue to retain our pride without lingering at the altar of personal

ambition. We must transform without transgression, share without imposing, and integrate with interrupting. 

Basically, we are not supposed to rock the boat.

I think it is time for a little rage, a rage that is called PMS when it comes from women, but it is called assertiveness and initiative when it comes from men. I think it is time for a more enlightened equality. When our male

colleagues have been asked why is it that we have not excelled as much as they have, they attribute the lack of

progress of women in research to a lack of general management or line experience or not having proceeded far

enough through the institutional pipeline. That is the man’s response. However, when women have been asked 

the same question, they have suggested that it is the exclusion from informal network, added to the lack of opportunities, and the lack of support services that were the major barriers to progress. The sad truth is that even though, 

at the dawn of the millennium, we are living longer as women — we are not living better.

I would like to challenge you today. I believe that the time has come to bring to the table the discussion of

women’s issues and our research agenda, and then address them accordingly. After all, it has been said that justice 

will return to Athens when those who are not injured are as indignant as those who are. The time has come to

close the gap of what we say and what we do. After all, most people enjoy the comfort of opinion without the 

discomfort of thought.

So what are we going to do? I tell you that in the year 2000 we will have 137 million women, 47,000 of 

us alive past the age of 100 years; we will make up 48 percent of the labor force of this country; 70 percent 

of us have children under the age of 18 and we work; 18 percent of all firms in the United States are headed 

by women; and women older than age 65 will outnumber men of the same age two to one. So if we are going 

to be the largest numbers, and hopefully, not only in nursing homes, I can tell you that the time has come to 

find out why is it that the greatest deterrent for women not achieving their potential is gender bias. For that, 

I tell you I am not all together encouraged.

In my view, the greatest hope for women of today is recruiting, training, and retaining and then demanding 

that women are treated as equals: encouraged by schools, propelling to academic excellence by the universities,

recognized by their male counterparts, and appointed to positions of distinction by their merit equal to men. 

The problems the world faces are too large to solve with only half of the brains of the world at work. I can tell 

you that ignoring the talent of half of the human race assures mediocrity.

In my mind, many of women’s problems reflect a lack of empowerment in the planning process and lack 

of accounting for the societal problems that affect us throughout our lives. Again, what do we do? I would say 

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the first thing we have to do is follow like a hound dog the development of our research agenda, something 

that goes hand in hand with better data. You don’t know how depressing it was for me to find that the only 

data I found about our research was from the early 1990s.

When we look at our data we must try to get current data, because how can our research institutes and the

agencies begin to shift funding in the direction of women’s research when so little is known about the numbers,

the severity, and prevalence of the very areas that warrant the greatest research funds? How can our researchers

focus on the diseases that are killing women — HIV/AIDS, cancer, tuberculosis, diabetes, and heart disease — 

when epidemiologic data are sparse at best and nonexistent at worst. 

The data on Hispanics in this country only became available in 1989 when we had the first Hispanic notation on the death certificate and on the birth certificate. We are 64 percent Mexican, 11 percent Puerto Rican, 

5 percent Cuban, and 7 percent who still do not know where they came from. Out of 266 million Americans, 

15 percent are African Americans, 9 percent Latinos, 3 percent Asian Pacific Islanders, and 1 percent Native 

American. We still have only data that say African Americans, whites, and others. How can you plan for me if 

you still do not think I exist? May I remind you that by 2014, the largest emerging majority of these United States

are going to be these minorities, and you better shape your act together because we are going to be here to stay. 

I think the time has also come to address the difficulties regarding women’s research and try to take away 

the perception of researchers and help them really do what is necessary. For example, most women’s health has 

historically meant gynecological health. There is a perception, however, that linking the health research needs of

women and children inevitably equates the value of women with bearing and caring for children only. Similarly, 

as well in some bureaucratic minds, it is assumed that when you link maternal and child health concerns, the 

linkage implies a tacit ranking of child concerns above maternal needs. I think the time has come to tell people

that I love children, but as women we need our position in this country, and more than anything, we need it 

in a more broader case than gynecological. We have many more diseases that are killing us.

Equally important, researchers desire homogeneous study populations with perceived assumptions that

women’s cyclical hormonal changes would confound research results. Don’t these researchers know that the 

potential for gender differences in research is exactly what we are looking for? 

Scientists believe, as well, that it is more costly to recruit women because they need help with child care 

and transportation. Ladies, these problems are not different and not necessarily more expensive. If you pay 

attention to issues like these, the best thing you are going to get is better protocol compliance.

Likewise, researchers believe that studies are more expensive when they must test gender-specific hypotheses or complete subgroup analysis by gender. The truth is that if women had been included when they did the 

20-year aspirin study and the 20-year aging study, they would not have had to duplicate the studies, which cost 

them even more money. Surely, it would have been cheaper to include both genders initially. The time has come 

for researchers to understand that 52 percent of the taxpayers of this country are demanding that research funds

paid by them are used in their research as well.

In the recent past, the fear of harming pregnant women and their fetuses led researchers and policymakers 

to adopt protectionist policies that excluded not only pregnant women but also fertile, non-pregnant women who

wanted to participate. Researchers must realize that there are women who are unlikely to become pregnant or may

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delay pregnancy altogether and therefore would be wonderful research subjects. Again, researchers must 

realize that a virtual ban on research participation for all women of childbearing age is an excessive response 

to unfounded fears.

I believe that perhaps women’s health has been neglected because of an unconscious sense in the mostly 

male research community that issues pertaining to women are of secondary importance, especially if the issue 

has already been studied in men. The truth might be that in this publish or perish world, many researchers avoid

repeat studies, particularly if the studies show no significant differences and, thus, not publish it. In the future, 

we must be able to promote research more as a life-saving tool rather than just an extension of your bibliography.

Now, what do we do next? We have heard enough rhetoric, enough double talk, regarding the women’s agenda,

and have seen very few changes in response to our requests. I believe that the time has come for action, and we

need it today. Stalling women’s agendas for perceptions rather than realities is not only bad politics, it is bad economic policy, and it is bad public health policy. I have to tell you it is time to reap the benefits of our work and 

see where are we going from here. It is time to fold the barriers and put them outside the door. We need clear

thinking; absolute ends to self-limiting attitudes; a real appreciation of intellect, training, and accomplishment 

of women in all fields; and an insistent, even aggressive, self-appreciation of our worth.

We might be more complex, but the time has come to stop all the things that have kept us behind and get us

back on track. If we have done one thing in life, it is to believe that the degree of caring in America is ultimately 

a function of our leadership, but no amount of leadership can save us if we do not want to or we do not know

how to save ourselves. Remember, if we are to succeed and promote our research agenda, we, the promoters and

the policymakers alike, must step in the shoes of the unfamiliar before we develop programs that are responsive 

to the needs of those people entrusted in our care. As the Indian proverb says: Don’t tell me what to do unless 

you have walked a mile in my moccasins. 

In that sense, to succeed we must learn to develop partnerships, not only among ourselves but among local

research groups and universities and among the communities that we serve. If we do that, I can tell you that we

can combine skills, specialties, and ensure more comprehensive services as a result. 

Again, where do we go beyond Hunt Valley? Allow me add my counsel to what I am sure you have already

discussed and will be discussing in the future. First and foremost, when you get to your work please don’t forget 

to keep up the momentum of our meaningful interchange and do not allow the pace to slacken in the face of other

pressing commitments that await our return to daily life. Above all, let’s search for creative solutions, and some

come to mind. 

There are three things that I think we should avoid: first, throwing out what is good; two, smugness and 

complacency; and three, looking back too much and forward not enough. First, don’t throw away what is good.

You must wonder why I ever suggest such a thing when we may be in danger of abandoning the principles and 

the mechanisms that have been responsible for the premier research system. If we think about it, there are pressures that are edging toward just that. Difficult financial times, for one, may force us to abandon the integration 

of teaching, publishing, and research. I believe that instead, these activities need to become even better integrated 

and mutually reenforced. We must be teaching, publishing, and research communities in the deepest sense, 

and we must do all that we can to protect that endeavor.

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Above all, I say that we must ensure that the velocity of the political debate that happens in Washington today

does not make women and their research agenda a political football used by liberals, conservatives, or whatever

they want to call themselves, as a mere rhetorical tool to press some ideological agenda. Politics is rough. I know

from experience, but there is never any excuse for turning the human needs and claims of women into the hollow

utility of rhetorical or political gamesmanship. We should know better than that.

Second, don’t fall prey to complacency or smugness. The excellence that we have attained in our agenda 

does not mean that we should not incorporate or accommodate change. Our own worst enemy can become 

smug and complacent, and we could be guilty of both. We must honestly and continually assess what we are 

doing and how well we are doing it. The instability in health care financing and delivery has placed enormous 

pressures on research and on different professional groups, including our own. But, it is important that we do 

not fool ourselves that what is best for health institutions is what is best for women’s research. This is an important distinction, one that we keep in mind as we push for research and then target the monies for research, 

even when we work in an institution.

Finally, stop looking to the past instead of the future. We cannot justify the investment of federal monies 

just because we want to benefit the future generation. Send me the money and shut up is no longer an acceptable modus operandi. Instead, we need to look to the future, conceive improvements of our role in the national

agenda, utilize the very technologies we have helped develop, improve communications both inside and outside

our departments, and then learn to sell our ideas more effectively to Congress, to review committees, and 

to the scientific review boards.

At this point we need to work more aggressively to prepare ourselves for the international, globally integrated,

environmentally challenged world that we are entering. We need to tailor our agenda to encompass the demands 

of the new marketplace. But in doing all that, we must not forget to humanize the research environment. We need 

to think carefully about the issues that concern the everyday woman researcher, issues like laboratory availability, 

economic security, and tenure ship in the long run. We need to work effectively to include more women in

research and retain departmental excellence. 

The time has come to hold top management accountable for women’s lives and women’s promotions. More

than anything women have worked very hard and deserve a chance to move into the ladder of opportunity. Institutions in the future will have to sponsor daycare, support programs for the elderly parents, job sharing, and flex

time. Women today are spread unbearably thin for all they have to do, and, as a consequence, we feel terrible,

destructive guilt about slighting children at home or having to work and leave your family. Maybe it is time to 

recognize that the superwoman notion, although a great concept in today’s world, might not be totally realistic. 

In the long run, a woman’s life is all about choices. But more than anything women must continue to take risks 

and offer challenging assignments where they can show their true worth.

Having said all that, we must acknowledge that women have been slighted at work, whether it is consciously 

or unconsciously. Therefore, women do not deliver the sermon of equality but live by it. By that, I mean do not

preach in the dark and continue to practice the abuses of power that we so much criticize. I mean things like 

withholding information, leap frogging through hierarchy, lack of clear expectations for employees, displacement 

of deserving professionals at work, and in publications, unfilled promises and inequity of salaries. None of these

are to be tolerated. They are called abuses of power. We have tolerated them enough. The time has come never 

to do that, even more so when the boss is one of us.

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Finally, I will suggest another arena where we should be more active, and that is advocating our cause. Though

we must not blindly advocate our cause, we absolutely must advocate it. That means go to the editorial pages, 

in the television news, in public lectures, in the most popular magazines, and in local political gatherings.

The future has no political constituency. We must become that constituency. We must raise the level of debate.

We must show the relevance of research to society and especially how the average life of every American will 

be safe because of the research that we conduct. More than anything, we do not need to engage in hyperbole,

because we have a wonderful, strong defensible cause. 

To be realistic, this new advocacy must not be done in the abstract. It can only work if it reflects the wisdom 

and the suggestions of those of you who are being touched day by day by their research experience. It must

embody your desires as well as your needs, and it must become an extension of your courage. If this is not 

accomplished, then the system only serves itself, but not the people for whom it was intended.

I can tell you that there is an infinity of important things to discover, understand, and apply. We, as a group,

cannot lose our will if we are to continue our great adventure. But, as we listen to each other here, let’s remember

that when solutions come our way we can no longer sit there and expect things to happen without us participating. We absolutely must watch over the process and participate in the outcome. Those of us who have the power

of speaking for those who cannot communicate must absolutely do so loudly, clearly, and constantly.

So as it was said in Kismet: “Why be content with an olive when you could have a tree? Why be content to 

be nothing when there is nothing you couldn’t be? Why be content with a grove when you could have the world?” 

Colleagues, Yehuda Bauer said it best: “thou shall not be a victim; thou shall not be a perpetrator; and thou

shall not be a bystander.” In the lives of women, their future, and their research, let none of us ever be bystanders. 291

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Maureen Henderson, M.D., Dr.P.H.

Emeritus Professor of Epidemiology and Medicine

University of Washington

Member, Division of Public Health Sciences

BEYOND HUNT VALLEY: PERSPECTIVES Fred Hutchinson Cancer Research Center

I

was able to participate in the Hunt Valley workshop 6 years ago, and I took the time to review the proceedings of that workshop and the research that I knew and could learn about. I thought about the picture as 

a whole and tried to think about the overall development of this program.

As a result, I will make three suggestions. The first suggestion is to focus on research priorities. The last 

6 years of active development of this program seemed to highlight issues more than research goals. We talked

about agendas more than priorities; strategic plans more than systematic studies; and short-, rather than longterm results. Looking at the picture as a whole, the trend seemed to have been towards applied, rather than basic

research; therapeutic, more than causal and prevention research; and one disease or categories of disease at a time,

without attention to cross-cutting and underpinning mechanisms and towards current, rather than new hypotheses.

The cross-cutting mechanisms include immunocompetence, the foundation of healthy reproduction, healthy

growth and development, and healthy old age. We do not really know its determinants and what maintains it.

Another is the regulation of mood and emotion, which influences not only the depression that threatened those 

of us that are in my age group but also cancer, heart disease, and obesity. Others are the regulation of body mass,

which influences heart disease, cancer, and diabetes, and the new cardiovascular risk factors and mechanisms.

There is much less smoking, even though we know it is a problem in women. There is less uncontrolled high

blood pressure, fewer homebound mothers. In those settings, what are today’s most common predictors of coronary heart disease in women and how do they work? Finally is the mechanism of long-term, low-dose exposures,

and I do not mean just exposures to environmental chemicals and toxicants. We have to think about natural products like vitamins and beta-carotene. We have got to think about common treatments, drugs used to lower high

blood pressure, hormones, mood-controlling drugs, and obesity drugs.

My first suggestion, therefore, is to begin work on the integration and prioritization of the research agenda and

move towards rebalancing priorities to include more basic science and more of the risky cutting edge of science.

My second recommendation is to do what I would call process research, a part of health services research. 

I want to emphasize a feature that I believe has really been nurtured by women’s health research and that is community and science partnerships for targeted research. The goals and responsibilities of these leadership planning

and management partnerships are varied and include one, some, or all of these tasks at different times.

The membership of these groups also varies enormously in background, types of commitment, and personal

agendas. The success of these groups, from time to time, can be studied scientifically, and we can learn for the

future the best composition of groups for different sets of responsibilities. We must be able to plan much more successfully to appoint groups to share in these partnerships and be as successful in deciding upon and monitoring

our research as we would like them to be. At the same time, we need to clearly differentiate this innovation from

specific sociological and public health intervention strategies such as participatory research, community level 

interventions, community organization, and population-based research. I am continually bothered by the lack 

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of communication among people who are using these words and who are not clearly communicating what we 

had in mind when we used them. I believe there are appropriate social scientists who analyze the interactions 

of these groups who are working so well in these fields and begin to give us some rigorous description of the

process and the success.

My third suggestion, which may sound retrogressed, comes from my time in medical school, in the late 

1940s and early 1950s. I went to a medical school in England that had a very active department of pediatrics 

that engaged in community-based pediatric teaching and research. We all were out in the community learning

about children, and they did a cohort study of a random sample of families in Newcastle, where the medical 

school was based, to look at what they could do, the pediatricians and the family practitioners, about improving the health of children, which they knew was not good in that city at that time. 

The book they published went into descriptions and analysis of the health of the children and what could 

be done about them, and the authors came out with a recommendation that did have an impact on British health

care. At that time with the tools available, the authors believed that the mothers and grandmothers could do more

to promote the health of the children than the pediatricians and family physicians. They recommended that there

be an organized effort to educate the mothers and the grandmothers to provide them with the knowledge and tools

and the backup of the public health agencies. They, of course, pointed out that we still should do research, biomedical research to find new ways and new tools that the physicians could use. At this time, in terms of the healthrelated behavior of adolescents and such things like cigarette smoking and teenage pregnancies, an approach like

this could be considered for dealing with some of the very important problems in young women.

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Barbara Ross-Lee, D.O.

Dean, Ohio University 

IMPLICATIONS FOR EDUCATION AND PUBLIC POLICY* College of Osteopathic Medicine

I

always felt that the first years of my education as an ethnic minority were a challenge, until I entered 

medical school. Then I realized that I had two major challenges, and the second related to my gender. 

In the world of medicine and medical education, particularly in administration, I wear a couple of 

minority hats: I am black, and I am female.

Another challenge is that I am also an osteopathic family physician, which means that I wear another hat — 

a minority hat. When you wear that many hats you either have to stand tall and be proud, or you curl up and 

die. So I am probably one of the most arrogant, black, female, osteopathic family physician deans that you 

will ever want to meet. 

My very first lecture in medical school was delivered by a pathologist who ended his lecture to this brand 

new class and this brand new school of osteopathic medicine with words of advice. His words were: “Remember

students, you are what you communicate.” I thought that was really profound, that if I acted like a professional, 

I would be treated like a professional. Then I realized that therein lay the basic difference in medicine and in health

and in the medical profession. My fellow students, certainly, could take those words at face value, but I learned the

hard way that it was not so much what I was communicating, it was how I was being perceived. To a large extent,

as a woman and as a minority, in all avenues of health care, whether as a patient, a professional, or a physician, 

I ultimately was treated based upon the stereotypic perceptions of the population or the person I was dealing with.

It came as a rude awakening because it is hard enough being black and interacting and also having to carry

the mantle of my gender. I learned the hard way, in many instances, that it was more difficult being female than 

it was being black in a health profession. 

Little girls don’t grow up wanting to be the President of the United States because this option is not presented

to them. Certainly in medical education, females are not presented with the possibility of becoming dean of a medical school. After being in medical practice for 10 years, I knew there had to be a better way for patients, particularly

vulnerable populations of women, children, and minorities, who made up my practice, to be treated by the health

care system. I chose to go into medical administration to make things change, and I am still trying to do that.

First, I found that the medical education system, both its structure and its internal organization, colludes with

the absence of cultural and gender issues in the curriculum and with the ascendancy of women and minorities into

the medical professions. Actually, medical education has a significant proclivity towards the status quo. Much of

the change that has occurred in medical education has come about by the change in the student body and the

increased representation of women, and, hopefully at some time in the future, minorities. In fact, medical education for decades has cloned itself, and need I tell you what that clone looks like.

The evolution of medical education has focused heavily on research, and has been preoccupied with disease

research with an organ focus and an absence of population focus or life span issues. The issues in research that 

are most appropriate and extremely important for women were essentially reproductive health. 

* Presentation edited from meeting transcript.

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We have come a long way, and we have made some significant changes. This is not to imply that we are close

to where we need to be, but we have come a long way. We have a more diverse workforce. There are female health

professionals in medicine, nursing, and other related fields in much greater numbers than ever before. We have a

women’s health curriculum. We have opportunities to facilitate research on women’s health issues through policy

changes and funding strategies. We are beginning to see a broader population focus in the area of research. We are

starting to see outcome studies and research studies that can impact the way in which care is delivered or at least

give us some information about it. We are seeing a greater emphasis on primary care versus the organ system 

specialties. We are seeing a major emphasis on prevention and health promotion.

We are now seeing managed care, which ideally will promote prevention and health promotion strategies in 

the delivery of health care. Furthermore, managed care is important because more and more medical education 

has to partner with managed care to create a product that will meet the changing needs and the changing health

demographics of the society.

Historically, our service delivery system has depended specifically on the product of medical education and, 

for the first time in history, medical education must now respond to the service delivery system. This is a very 

significant power shift, which, from a policy perspective, we can now start to take advantage of. That will be 

difficult because one of the things we do not recognize is the fragmentation in medical education — first, in the 

way medical education is structured, but also from a policy perspective — what are the policy institutions that 

can have an impact on medical education and where will that impact be. 

At the federal level, we have the Medicare and Medicaid programs that impact health and health care and, 

in fact, Medicare and Medicaid impact graduate medical education through funding strategies. We have research

funding at the federal level that can provide incentives to improve research on women’s health issues, and we 

have educational grants at the federal level that can provide incentives. Finally, we have the Department of Education that focuses on standards and accreditation issues and makes sure that those things occur. 

The states also have policy agencies and institutions. Licensure occurs at the state level. Standards and expectations for the practitioners are set at the state level. Undergraduate and predoctoral education are funded at the

state level, particularly through the public schools. You also have subsidizing of private medical education on the

state level. The states are in charge of Medicaid. Medicaid funds, in some states, go to graduate medical education,

and, interestingly and becoming more important to us, is that the insurance commissioners are at the state level.

The states are in charge of insurance, and the managed care organizations, of course, have to respond to the states

from a public policy perspective.

Professional policy seems to be an area where we have not been able to focus as effectively, but it has been

focused on the positioning of women in the health professions. The professional institutions and policies are set

based upon accreditation and certification. This is an important place to bring about an impact on women’s 

health and women’s health issues in the curriculum.

Even as we talk about the fragmentation of policies and policy arenas, medical education is fragmented and

overlaps through different authorities. For instance, the colleges are responsible for pre-doctoral education. The

academic teaching hospitals are responsible for residency training, and the professions are responsible for continuing medical education and certifications. To impact medical education, those levels must be impacted through all

of the various policy agencies to facilitate change. At best, redressing the fragmentation is going to be incremental.

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It is important that we look at education as a continuum so that our strategies, although incremental, can

occur over the full gambit of medical education. At the colleges, we are looking not only at the curriculum content,

but also the methodology. At the colleges, we certainly need to make changes to a more enlightened leadership.

That is not always easy. Much change can occur from the top if the appropriate tone is set, and we are becoming

more successful as women emerge through the system, but we still have a long way to go.

Teaching hospitals need to be a part of a consortium to facilitate this continuum. From policy perspectives and

changes in medical education consortia, emerge opportunities for partnering and therefore facilitating many curricula changes around the country, which can then address some of the issues of women’s health and minority health.

The osteopathic profession has established this continuum of education through the consortium approach 

as part of its accreditation process. We know now that we have an infrastructure. We can start to facilitate changes 

in curricula not just at the undergraduate level but also at the graduate level, and hopefully, at the continuing 

education level.

Whenever we mention continuing medical education, we focus on medical schools and residency training programming. More than 90 percent of practitioners who provide health care to women are not in medical school or

in residency training programs. We also know through funded research at NIH or at the federal level that changing

physician behaviors and attitudes and knowledge base once they are in practice is a challenge that we have been

unable to change significantly. If 90 percent of the practitioners can only be approached through continuing medical

education for licensure or for certification, then the policy arenas that we should be focusing on are the states and

the professions. If we want to incorporate much of the research into actual practice, which is a challenge, then we

need to focus on other areas of policy and public policy than just at the federal level.

I leave you with my suggestions for research. Number one, focus on the life-long learning portion of 

medical education, on the continuing medical education requirements, particularly at the state level and in 

the professional organizations. Second, we need further studies on how to change practice behaviors because 

that will be the next challenge if we are going to make any significant change in how health care is delivered 

on a daily basis in the many practices across this country. Third, with the changing environment, we need to

understand or study the impact of managed care on medical education curricula, particularly as it relates to

women and women’s health issues. 

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Lydia Villa-Komaroff, Ph.D.

Professor of Neurology

Associate Vice President for Research

WOMEN IN BIOMEDICAL CAREERS* Northwestern University

I

would like to begin this morning with a parable that I discovered about a year ago. I think that this parable

contains many elements that all of us must feel as we progress through our careers in any field. This is from 

a novel called Side Show by Sherry Tepper. 

Once upon a time, there was a turtle who lived in a pond with grey reeds, grey mud, and grey moonlight

falling, which is what a turtle sees because she does not see color. Not for her, the glory of the sunset or the 

wonder of the dawn; not for her, the flash of a hummingbird’s throat or a butterfly’s wings. For her, the liquid

sounds of water moving, the slosh and murmur of the stream, the wind in the trees. For her, the difference

between shadow and darkness. 

She was content, as turtles are content, to be deliberate in her habits and slow in her pace, to eat leaves 

and the ends of worms like fodder, and to think long, slow thoughts on the log with her fellows, where she 

knew the sunlight was warm, though she did not know it was yellow.

But a time came, on an autumn evening, grey leaf and grey thorn and grey mist rising, where she sat over 

long on the log after the sun was well down and the swallows came to drink and hunt on the surface of the 

pond, dipping and dancing upon the ripples, swerving and swooping with consummate grace so that the turtles 

saw them as silver and black and beautiful. And all at once, with an urgency she had never known before, she

longed for wings.

“Oh, I wish I could see them more clearly,” she murmured to the bullfrog on the bank; “that I might learn 

to fly.”

“If you would see them clearly, you must go to the secret sanctuary of the birds,” said the bullfrog, in the 

careless voice, as if he did not take the matter seriously. And when the turtle asked where that was, the bullfrog

pointed westward to the towering mountains and told the turtle the sanctuary was there, among the crags and 

the abysses where the birds held their secret convocations and granted wings to certain petitioners. 

The turtle thought how wonderful it would be to go there and come back and tell the bullfrog all about it. 

On the next night, she asked again where the birds went when they left the pond, and the owl pointed westward

with its talon, telling her of towering peaks and breakback chasms, in a calm and dismissive voice. And again 

she thought of making the journey, and the wonder the bullfrog would feel, and the owl, to hear of it when 

she came back.

On the third night she asked yet again, and this time it was the bat who answered, squeaking as it darted 

hither and yon, telling of immeasurable heights and bottomless canyons. “No one dares go there,” the bat

squeaked, but the turtle herself, if she dared, even if no one else would.

* Presentation edited from meeting transcript.

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So for three nights the turtle watched, each night her longing growing. And at midnight on the third night,

when the bat had spoken and the swallows had departed, the turtle went after them without telling anybody 

goodbye, slowly dragging herself towards the great mountain structure towards the west. She went by long 

ways and rough ways and hard ways, always. First across the desert, where she would have died of thirst, had 

not a desert tortoise showed her how to get moisture from the fruits of a cactus; and then across the stone, where

she would have died of hunger, had a wandering rabbit not given her green leaves to eat; and then into the mountains themselves, where she would have given up and died many times, except for her vision of herself going 

back to the pond to tell all of the creatures there of this marvelous and quite surpassing quest.

They didn’t know, the turtle told herself, they had no idea what it would be like. They made it sound easy, 

but when I go back and tell them what it was really like . . . . She dreamed of the cold nights away, visualizing 

herself telling her story to her kindred turtles on the sunlit log and to the bullfrog among the weeds and to 

the owl and the bat, all of whom would be admiring and astonished at her bravery and perseverance.

And so, sustained by this ambition, she went higher and higher yet. Grey stone and grey cliff and grey rain

falling year after year, until she came at last to the place where the swallows danced in the air above the bottomless void. When they saw her, they stopped dancing to perch beside her on the stone. And when she saw them

there, silver and black, beautiful as the night lit with stars, she was possessed once again of a great longing and

told them of her desire for wings.

“Perhaps you may have wings, but you must give up your shell,” they cried. And even as they told her 

she might have wings, she seemed to hear in their voices some of the carelessness she had heard in the voice 

of the owl and the bat and the bullfrog, who had told her to go without telling her of the dangers of the way.

She heard rightly, for the winged gods have a divine indifference towards those who would seek flight. 

They will not entice, and they will not promise, and they will not make the way easy. For those who wish 

to soar must do so out of their heart’s desire and their mind’s consent and not for any other reason.

And the turtle struggled with herself, wanting wings, but not wanting wings. For if she had wings, they 

told her, she would no longer be interested in going back to the pond to tell the creatures there of her journey, 

that comfortable telling, the anticipation of which had been perhaps more important to her than the wings 

themselves. And so she struggled, wanting and not wanting.

I think, for those of us in biomedical science, that we find the path that we each must take as we seek our

own place within our field and in our own lives. I think too often we have told the young ladies and we ourselves

have been told that we can have everything, and we can do everything, and we can do what we wish. And we 

can. The problem is that, all too often, we forget that we cannot do everything all the time. We cannot be everyone,

everything, to everybody all of the time. There are choices that we must make.

The other thing that I think this parable tells us is the importance of the people around us. We are not supposed to make these journeys by ourselves. We must seek strength in each other. We will all need mentors and

peers. We are never too young to be a mentor, and we are never too old to need a mentor. We all need mentors 

at every stage in our career. We need someone with whom we can explore the job that we are doing, the manner 

in which we are approaching things, and to find validation for our own approach as we move into positions of 

leadership in this enterprise.

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There are clues. I mean, the bat and the owl said that there were deep chasms and mountains that could 

not be climbed easily. But there are times, I think, in our careers when we are not ready to listen to that, and 

that is probably good.

I think many of you in this room can certainly think about some of the hard jobs that we do in the laboratory and in the offices and in the administration and in the patient care room, and we know that we don’t tell 

the bright, young students about many of the difficult times, but they will be there.

I’m not sure that that’s a favor. I think we should tell them how hard it is, because it is important; that as 

people go forward into this career, that they have their eyes wide open, because we are certainly needed in the

halls of power, at the universities, and the hospitals. The points of view that women and individuals of different

backgrounds bring to those kind of endeavors are critically important as the nation changes, and we will have

done ourselves no favors if we either elect ourselves out or go into institutions where we are not allowed.

But you do have to know that it is a battle. I think many young women today believe that they will not 

run into problems as they progress because in school, in medical school, and in at least most graduate fields,

women do not have trouble as they enter as students. However, all of us know that as you get higher and higher, 

then it can become ever more difficult, and there have been many times where it is apparent that the pathway 

to the very top is one which is open only to a very few, and those very few must be those willing to make 

enormous sacrifices to get there. 

The specifics of how one gets to any particular place are not very important. When I was a graduate student, 

the only thing I wanted to do was run a laboratory. It never occurred to me that I would become a bureaucrat.

However, a time came in my career when it was apparent that the contributions that I could make in the office

were perhaps greater than those that I could make at the bench. And so, after a great deal of soul searching, 

I closed the lab and moved into a position that now involves me in science at a very broad level; so that my 

broad interests now become a strength rather than the non-focused kind of critique that one gets in a grant.

So often, despite what the world says, you must know your own strengths and weaknesses, and you must 

be able to move with them when those opportunities arise. Very frequently, it feels like jumping off a cliff, but 

that can be invigorating and freeing and can allow you to maximize your own potential.

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Margaret A. Chesney, Ph.D.

WOMEN AND HEALTH: Professor in Residence, School of Medicine

TIME FOR A NEW PARADIGM University of California, San Francisco

There has been an increased focus on women and health in the last decade. This is evident by the number

of conferences, such as this one, devoted to the topic. Journals, monographs, and books are proliferating

and striving to define the field. Although the term “women’s health” is widely used, it lacks a clear definition and has been the target of debate. Efforts to arrive at a definitive conceptual model are likely to fail because

the field is dynamic and any model would inevitably become dated. As an alternative, a framework has been proposed for the field by Chesney and Ozer as the first article in the inaugural issue of the journal, Women’s Health:

Research on Gender, Behavior and Policy.1 This framework is illustrated as a multilevel circular figure that characterizes the evolving quality of the field of women’s health. At the top of the multilevel framework are the key content

areas of women’s health. Included are topics that have traditionally been considered, such as reproductive health,

which addresses the key issues of hormone replacement and infertility; diseases more common in women than in

men, such as breast cancer, depression and eating disorders; and the leading causes of death among women, most

notably coronary heart disease, lung cancer. More recently studied topics in women’s health also highlighted in 

the top of this multilevel framework are gender influences on health risk behaviors such as smoking, alcohol, and

physical inactivity; societal influences on women’s health, encompassing social norms and roles, as well as poverty;

violence against women, and women and health care policy. 

A feature that often sets research on women’s health apart involves the processes and methods that are used 

in conducting research. Thus, the second tier in the multilevel framework, beneath the content areas, are processes

and methods. These approaches span each of the content areas and include, for example, increased attention to

diversity of populations of women in health-related studies. Thus, this tier suggests that each of the content areas

in the top tier would be investigated in diverse populations of women. Similarly, other methodological issues that

span the topic areas of women’s health include careful examination of the appropriateness of research questions,

variables of study and research tools to research on women. For example, variables such as “number of children,”

“work,” and “social class” need to be very carefully defined so that they capture the important domains that are

necessary for understanding and addressing problems important to women’s health. Specifically, variables that

might work well in studies with men should not be automatically transferred to research on women. 

Finally, another tier that is most important in a framework for women’s health is represented by the various

conceptual models that characterize the work of the numerous disciplines involved. These disciplines include but

are not limited to anthropology, sociology, nursing, psychology, epidemiology, and medicine. Each of these disciplines brings expertise that is important to the field of study. Indeed, women’s health is best studied and advanced

by a multidisciplinary perspective. It is apparent that traditional models, particularly those that are competitive and

“reductionistic,” are not adequate to address the needs in the area of women’s health. The proposed framework is

designed to be an alternative to more traditional models in that it is collaborative, dynamic, and respects multidisciplinary and interdisciplinary perspectives. This framework implies that the field of women’s health will expand 

best if those engaged in the research work together and join forces.

Reference

1 Chesney MA, Ozer EM. Women and health: In search of a paradigm. Women’s Health: Res Gender Behav Policy 1995;1(1);3-26.

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Byllye Avery, M.Ed.

PUTTING IT ALL TOGETHER* Founder, National Black Women’s Health Project

First, I want to pay honor to the women’s health movement. I never speak before a group without recognizing the women’s health movement, which is the reason for our being here. It is especially significanttoday to be in the room with sisters who helped to start this movement some 20-plus years ago; my hat 

is off to you. I also say it because I want every one of you to know how you got here. 

No one opened the door and said, don’t you women want to come and talk about health? It didn’t happen 

that way. It happened because women took risks, put themselves on the line, and were called everything just 

to get our health care system to be more humanistic, to share information with us, and to give us the service 

that we deserve. It is a model for everyone.

Someone spoke this morning for the men’s health movement. We need the men and women to work together;

this is not just about women’s health. What is important is the perspective that we as women bring to the situation. So, when my black brothers ask, why didn’t you start a black men’s movement, I say, I don’t know. I don’t

know how you feel about your health, and you deserve to have your own perspective brought out. Women’s 

health can only go a certain distance without the men. I say to you men, you better get on it, because you 

have 20-plus years to catch up. But I know you can do it.

I do not want to forget that racism and classism still plays a large role in the lives of many of us. It cannot 

be taken lightly. Yes, we are talking about race again. We have not done very much work around it, and we 

need to continue. Race is a difficult subject, but it’s worth it. It has penetrated the fabric of our society, and 

we carry out racists acts, whether we know it or not. We unconsciously carry them out, and we have to work 

hard so that we do not continue to internalize all of the negative messages that have been brought to us.

As you start to do your research, I want you to remember several things. First, there is power in telling 

stories. So, when you work with women, one of the most profitable, beneficial things that you can do is 

take the time to listen. 

Now, I know you are going to say I’m busy, I don’t have all that time, but do you want to be successful? 

Everybody has a story. When you learn to listen actively, you will get the answers you need. Give your full 

attention; do not say, this woman doesn’t know what she’s talking about. Not that kind of listening. Do the 

kind of listening where you bathe her entire presence with your attention. That attention becomes healing 

for her and for you. You will find out what you never get from questionnaires or telephone polls; you will 

get what you need if you are able to give yourself up. You will also have a story to share, because just as you 

are looking at me, I am looking at you, and I want to know about you. In this exchange, you build a relationship that will enhance all of your work. 

It is really important that the affected population be part of all phases of research, and there are enough 

people who are affected who think the way you think, who have the information you need, who are living 

with the diseases or the conditions, and who can be involved. 

* Presentation edited from the meeting transcript.

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We are all health consumers. If you don’t think so, let something go wrong with you, and you have to 

turn yourself over. Then you will understand what it is like to be a consumer. We only need to look at the 

AIDS and the breast cancer movement to see the power and the change, the energy, and the insights brought 

about by having the affected population be a part of designing and implementing whatever program you are 

thinking about. Whatever questions you have, input from the affected population is absolutely necessary. 

There’s a lot of talk about recruitment and retention [in clinical trials], especially for people of color, because

you can’t get enough from studies, because we don’t trust you. We don’t trust you. We have Tuskegee, we’ve got

every other ‘skegee and everything else that comes up. We get these contradictory messages that tell us to do one

thing today and something else tomorrow — all that is confusing. So, the lack of trust has got to be worked on. 

I am not going to tell you how, that’s something we have to figure out.

The second point is that when you are want to get people of color and people of low income levels to participate, you have to support their participation. I have several friends who participate in studies. Although they 

are middle class working women committed to health, it is still quite difficult for them to participate. You need 

to design something less complicated that can still get you the information. I’m not so sure having something 

very complicated is going to get you what you want, because you have to remember that you are working with

people. This is for people, and people need to feel involved and be part of the planning.

I want to raise another issue: Often, when people talk about working with special populations and low 

income people, they always think about us black folks or about other people of color. But, poor white people 

out there need to be thought about too. If you work with poor white people, you would understand what poor

people need, then you might be more apt to make sure they get what they need, because when you look at a 

person, you see a reflection of yourself, and then you understand what’s going on in a different way. So, please,

include poor white people in your work. There are plenty of them around that need to be included.

We, in the National Black Women’s Health Project, also advocate a holistic approach to health. We can’t 

afford to be involved in the disease of the month. We can’t afford to be taken in by marketing, because it’s easy 

to market and get involved in one specific disease or the other. We are working on a special program with the

American Heart Association — Walking for Wellness — because we are very concerned about cardiovascular 

diseases in black women. We are concerned about our weight, we are concerned about our not exercising and

doing the other stuff you’re supposed to do. We all wish we could be like Oprah and hire a cook and a trainer. 

But since most of us can’t, we’ve got to figure out a better way.

When we told the folks at Heart that we would enter into a partnership around Walking for Wellness — 

last year we tested out our program in two cities, and this year we are moving to six markets — we said it is 

crucial that we talk not only about the heart. We wanted to talk about our whole bodies, because the first 

thing sisters will say is my heart is in my body next to my lungs, next to my liver, next to my breasts . . . .

So, once we get the attention, we cannot afford to talk just about one thing. We need the holistic approach. 

It’s absolutely necessary. If you don’t do it, you’ll be blown out of the water because people will confront you 

with their own thinking in our communities.

Last, I want to talk to you as a healer, as a person who is participating in helping us be all who we are 

through health. I think health is the most important thing that we can organize and work around. Health 

cuts across all classes and all races; it is a unifying field to work in.

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You also have a lot of power. You have a lot of personal power in your daily dealings with both your colleagues and with the people who come to see you. Take that personal power seriously. Be careful what you say 

to people. If you are in a rush and you don’t have time, don’t bother with folks on that day because you undo

more than you build. Be careful about what you say.

You also need to take care of yourselves. We have become a nation of tired people. You are worn out. You’re

glad to be here at this meeting because last night you didn’t have to do anything for anybody. You could go up 

in your room and do whatever you want to do. You didn’t have to drop the kids off at school; you didn’t have 

to deal with daycare. We have all these labor saving devices, you have cell phones, you have beepers, you’ve got

snail mail, you’ve got e-mail, you’ve got faxes, you’ve got voice mail. We are supposed to be working less with 

all these things, but we are working more with all of them. No wonder we are tired.

I want to give you my prescription for wellness. It is perfectly all right for you to take one hour every single 

day of your life to do absolutely nothing. You need to be replenished, clear out the cobwebs of your mind, get

rejuvenated. Let me just tell you how I want you to design this hour. When you go home, have a meeting with

your family. Let them know that from now on you’re going to be taking an hour every single day. And give your

children the telephone number to the police department, the emergency room, anything they might need while

you’re taking your hour. When you go home from work in the afternoon, go for a walk by yourself. Don’t take 

the dog with you because, if you take the dog, the dog is going to be chasing cats and cars, and you’re going 

to have to take care of him. 

Or, do what I like to do. Get in the bathtub and take a bubble bath for one solid hour. Don’t do anything. 

Or go in your bedroom, close your door and lock it. Get in the bed. Let me tell you, you’ll feel much better 

about it. When I don’t do it, I find that I am angry, and I don’t know why. It’s because I had no time for me. 

Go to bed at night. Your body might not be tired, but your brain needs to rest. Go to sleep at night. We 

need to get enough sleep on a good mattress. But we get all carried away and think that we’re being productive 

and whatever, when, in fact, you’re just on a treadmill. 

I’m just saying slow down and start to live. Relax. Enjoy your life. You’ll find out that your work will 

be more rewarding, and you will feel so much better about yourself. 

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Public Testimony

INTRODUCTION

T O THE PUBLIC

TESTIMONY

3. To direct initiatives to increase the numbers 

of women who are participants in biomedical

research careers. 

ORWH does not function in isolation. We look 

to the broader community of scientists, health care

providers, and women’s health advocates across the

United States, and beyond, to ensure that the research

we foster and support and our priorities for research

reflect the needs and concerns of the women’s health

community. We rely upon members of the women’s

health community to provide direction for us in 

addressing their needs and concerns through research

and in pursuing the scientific knowledge that may 

permit the medical community to diagnose, treat, 

and prevent the adverse health conditions and diseases 

that affect women across the life span. One of the most

effective ways for us to accomplish this is through 

public hearings such as this one.

From the time of the establishment of ORWH 

and the structuring of our first NIH research agenda 

on women’s health, we have utilized public hearings 

to receive testimony from public representatives, and 

to build upon that testimony through scientific meetings and workshops to construct priorities for women’s

health research. 

The report of that first undertaking, Opportunities

for Research on Women’s Health, is based upon public

testimony and a scientific meeting held in Hunt Valley,

Maryland, in 1991.

Recognizing that there has been progress in

addressing women’s health through research, but 

also recognizing that the extensive focus on women’s

health has brought forward new concepts and scientific questions upon which we need to focus, we began

Vivian W. Pinn, M.D.

Associate Director for Research on Women’s Health

Director, Office of Research on Women’s Health

National Institutes of Health

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BEYOND HUNT VALLEY:

RESEARCH ON WOMEN’S

HEALTH FOR THE 

2 1 S T CENTURY

These public hearings, sponsored by the Office 

of Research on Women’s Health (ORWH), were held 

in conjunction with a series of landmark scientific

workshops designed to provide recommendations 

for the National Institutes of Health (NIH) agenda 

for research on women’s health for the 21st century.

The Office of Research on Women’s Health was

established within the Office of the Director of NIH 

in September 1990, by Dr. William Raub, then Acting

Director of NIH. ORWH was charged with the important role of providing a central focus for NIH-supported biomedical and behavioral research related to

women’s health issues, and with “...assuring that

research conducted and supported by NIH appropriately addresses issues regarding women’s health and

that there is appropriate participation of women in

clinical trials.”

The major mission of ORWH is:

1. To strengthen, develop and increase research 

into diseases, disorders, and conditions that affect

women, determining gaps in knowledge about

such conditions and diseases, and then establish 

a national research agenda for NIH for future 

directions in women’s health research; 

2. To ensure that women are appropriately represented in biomedical and biobehavioral research

studies, especially clinical trials, that are supported

by NIH; and,
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

this process to reevaluate the foundation for our

research agenda and to reformulate priorities as we 

go forward into the next century. Therefore, we began 

a process of revisiting our original agenda, based on 

the report, Opportunities for Research on Women’s

Health, often referred to as the “Hunt Valley Report,”

through a series of public hearings and scientific 

meetings, of which this is the final, and which we 

have called “Beyond Hunt Valley: Research on 

Women’s Health for the 21st Century.”

We began by establishing a Task Force on the 

NIH Women’s Health Research Agenda for the 21st

Century to assist and guide us, and our Congressionally mandated Advisory Committee on Research 

on Women’s Health, through this process. 

At our first regional meeting, held in Philadelphia

in September 1996, we began the process of reexamining our research agenda to ensure that it is relevant as

we move toward the next century. We held the first

public hearing at that time. During the New Orleans

public hearing and scientific workshop, in June 1997,

we invited discussion on aspects of the research agenda

based upon sex and gender issues, e.g., physiological,

psychosocial, and pharmacologic differences between

women and men. 

The third regional meeting, in Santa Fe, New 

Mexico, was designed to focus on factors that contribute to differences in health status and health outcomes

among different populations of women, and career

issues for special populations of women in science.

Finally, during the national meeting in Bethesda, we

held our concluding public hearing of this series and

brought together the results of all three regional meetings in this workshop. During the Bethesda public hearing, we specifically requested testimony addressing:

• State of knowledge and continuing or emerging

gaps in knowledge about women’s health across 

the life span;

• Sex and gender differences in health and disease;

• Factors that influence differences in health 

status and health outcomes between different 

populations of women;

• New priorities for research on women’s health;

• Career issues for women scientists: overcoming barriers and achieving success in 

biomedical careers.

NIH is the primary agency within the 

Department of Health and Human Services that 

performs, promotes, and supports biomedical and

behavioral research. Therefore, the focus of the public hearings was on research that should be initiated,

expanded, or enhanced to add to our existing knowledge about women’s health, as well as to consider 

innovative programmatic and collaborative efforts

appropriate for NIH to promote career opportunities for research on women’s health, and 

especially that of women in biomedical careers.

The testimony from all the meetings was received

and reviewed by our Task Force. The resulting information was used to guide the Task Force in developing recommendations for the NIH research agenda 

for the beginning of the 21st century. We are fortunate 

to have members of the NIH scientific community, 

as well as women’s health advocates, scientists, and 

health professionals from across the country serving 

as members of this important Task Force.

On behalf of NIH, and specifically ORWH, 

we thank all the participants who presented public 

testimony for their role in reassessing our research

agenda so that we can continue to make progress 

in women’s health status as we enter the next 

century. We are very appreciative of your efforts 

to share your wisdom and concerns during our 

consideration of issues of importance for the 

NIH research agenda on women’s health for 

the 21st century.
Mary J. Berg, Pharm.D.

College of Pharmacy, University of Iowa

Mary G. Bonk, R.N.

Complications of Gynecologic Surgery (COGS)

Women’s Support Group

Mary Ann Burg, M.S.W., Ph.D.

Florida Institute for Women: The Health Gatekeepers

University of Florida

Bente E. Cooney, M.S.W.

National Osteoporosis Foundation

Michael J. Gast, M.D., Ph.D.

Wyeth-Ayerst Research

Barbara S. Giesser, M.D.

Arizona Health Science Center

Phyllis Greenberger, M.S.W.

Society for the Advancement of Women’s 

Health Research

Mary Hammond, M.D.

American Society for Reproductive Medicine

Hazel J. Harper, D.D.S., M.P.H., F.A.C.D.

National Dental Association

Laura L. Hayman, Ph.D., R.N.

American Heart Association

Penelope J. Hitchcock, D.V.M.

National Institute of Allergy and Infectious Diseases 

Sexually Transmitted Diseases Branch

Lisa Kaeser, J.D.

Alan Guttmacher Institute

Virginia T. Ladd, R.T.

American Autoimmune Related Diseases 

Association, Inc.

SUMMARIES OF 

PUBLIC TESTIMONY

P H ILADELPHIA, PENNSYLVANIA 

SEPTEMBER 25, 1996

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309

Dorothy Mann

Family Planning Council

Rita M. May

Sjögren’s Syndrome Foundation, Inc.

Margaret K. McLaughlin, Ph.D.

Magee-Women’s Research Institute

Powers Peterson, M.D.

American Society of Clinical Pathologists

Marj Plumb, M.N.A.

National Center for Lesbian Rights

Linda Quander, Ph.D.

Clark Atlanta University

James M. Roberts, M.D.

Society for Gynecological Investigation

Roxanne A. Rodney, M.D.

Association of Black Cardiologists

Sheryl Burt Ruzek, Ph.D., M.P.H.

Temple University, Department of Health Education

Eleanor G. Shore, M.D., M.P.H.

Harvard Medical School

Martha Torres-Montoya, M.S.P.H.

Hispanic Women’s Health Association

Laura L. Tosi, M.D.

American Academy of Orthopaedic Surgeons

Jacqueline Lee Wolf, M.D.

Gastroenterology Women’s Coalition

Elizabeth Yoffe, M.A. 

Self
summaries of Public testimonY

310

Mary J. Berg, Pharm.D. Professor, University of Iowa

The University of Iowa is a research-based university composed of ten colleges, with a student body of 

approximately 28,000.

Dr. Mary Sue Coleman became the first woman president of The University of Iowa in December 1995. 

The presence of a female leader in this institution, founded in 1847, gives great hope to women in academia 

who are forwarding their credentials for promotion with the expectation that fairness will prevail.

The promotion and tenure list at The University of Iowa doubled from 1995 to 1996. This remarkable 

achievement was noted at the annual ceremony of the “Celebration of Excellence and Achievement Among 

Women” in May 1996.

Mary G. Bonk, R.N. Complications of Gynecologic Surgery (COGS) Women’s Support Group

Current U.S. public health policy, statutes, and state health laws adversely affect women who have experienced complications of gynecologic surgery. Occult obstetrical injuries to the pelvic floor and complications of

gynecologic surgery not made known to women may lead to progressive digestive and urinary dysfunction and 

disease. Diagnosis, information, and prognosis have been strictly suppressed by medical politics. Examples include

permanent ostomies surgically accomplished in the absence of fully informed consent; cancer, autoimmune diseases, and other disorders that may result from surgically implanted foreign material/devices; critical complications of gynecologic surgery such as post-hysterectomy pulsion enterocele and vaginal/rectal prolapse; and secret 

surgical research. Patients with postoperative pain and persistent dysfunction are often relegated to psychiatry. 

Information and health records of these conditions and injuries have been withheld from patients and

family/representatives under Georgia health law §31-33-2(c). Because all research in Georgia is tightly protected 

from legal discovery by Georgia health laws, the family/representative is also excluded from documentive research

information. Furthermore, we believe that health care data systems comprising patient information with diagnostic

codes, personal identifiers, and other categorical divisions are coded with psychiatric diagnoses, which blacklist

surgically injured persons and/or subjects of secret surgical research from all information and diagnostic health 

care except in a life-threatening event. Through mental health laws, interstate compacts, and committees there 

is reinforcement beyond state boundaries by codes with personal identifiers which blacklist the patient throughout the United States and Canada.

Investigative and documented procedures have been obtained on a patient from world experts outside of 

the United States and their assessments have been sent to the patient’s established physician in Georgia. Under

Georgia health laws and regulations, this physician cannot provide the information to the patient or representative,

and third party release of records cannot be obtained by process of Georgia law. In January 1996, a formal, written 

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complaint with request for investigation of this specific case was submitted by COGS to the Office for Civil 

Rights, HHS Region IV, in Atlanta.

COGS requests the interest of this workshop’s cochairs, leaders, and participants and asks for inquiries 

through the Freedom of Information Act to the Office for Civil Rights, HHS Region IV in Atlanta, Georgia. 

Mary Ann Burg, M.S.W., Ph.D. Professor in Academic Medicine, University of Florida

Our country needs major support to establish a National Network of Centers of Excellence in Women’s Health.

Without it, women’s health services will remain fragmented and insufficient. Although some of the lessons from 

the women’s health movement of the 1970s were absorbed by mainstream medicine, an oppressive climate still 

persists. Too many women have adverse experiences with the health care industry. Too many physicians disregard

their symptoms and “talk down to them.” It is clear that women’s health care needs are different from men’s, yet

they are not given the same attention and respect. This deficiency is reflected in morbidity and mortality statistics.

I believe that coordinating women’s health must be a top priority for those of us who provide health education, research, and services to women. A network of Centers of Excellence in Women’s Health is the most 

efficient and effective remedy for today’s disjointed service delivery system.

The Health Gatekeepers at the University of Florida offers a model for establishing a Center for Excellence 

in Women’s Health. We have built partnerships with other academic health centers and women’s research institutes

across the country to foster collaboration and linkage on the national level, which is essential to make a significant

impact on women’s health. In fact, we intend to construct a first-class National Center for Excellence in Women’s

Health to foster cooperative efforts to build upon existing efforts to improve the sharing of data, the mentoring 

of researchers in women’s health, and the development of models for delivering women’s health services.

A long-term strategy is critical to the success of a project like a national network of Centers for Excellence. 

It will require a concerted effort from foundations, philanthropies, and other private funding groups, as well as 

volunteer organizations. It also needs formal sanction by a host academic health center in order to have the influence necessary to survive in today’s political environment. The Brain Institute of the University of Florida, which 

was founded 5 years ago by a coalition of educational and research interests, provides an exciting model for 

establishing a unique, dedicated facility.

One of the lessons learned from the 1970s self-help movement — the foundation for the very notion that

women’s health is a unique field deserving distinct services — is that in order for a cause to flourish, it must be 

firmly institutionalized. The recent RFP from the Department of Health and Human Services to develop a Model 

Center of Excellence in Women’s Health is an exciting start to institutionalizing women’s health. Now is the 

time to capture this strategic opportunity.
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Bente E. Cooney, M.S.W. Director of Public Policy, National Osteoporosis Foundation

A comprehensive national strategy to address osteoporosis including a coordinated program of basic, clinical,

and behavioral research is urgently needed before the baby-boom generation reaches the age of osteoporotic fractures. Although progress has been made during the last 5 years towards preventing, diagnosing, and treating this

disease, there are still unanswered questions that need to be addressed. 

The National Osteoporosis Foundation is the only national nonprofit organization solely devoted to reducing 

the widespread incidence of osteoporosis. The major goals of our research are to uncover the molecular and cell

biology of bone and the factors that regulate bone cell activity; to identify the genetic and environmental risk factors that contribute to bone loss; and to develop methods of prevention, diagnosis, and treatment. Because women

are four times as likely to develop the disease, and based on data provided by the National Health and Nutrition

Examination Survey, NOF estimates that by the year 2000, a total of 25.5 million women either will have osteoporosis or be at risk for osteoporosis due to low bone mass. Therefore, we encourage and appreciate the continued

research efforts on osteoporosis, especially as it relates to women. It is our hope that research will address those

unanswered questions women need to learn about osteoporosis. 

In basic research, questions concerning restoring and reversing skeletal functions need to addressed. Moreover, investigation surrounding predetermining factors such as menopause, hereditary factors, and the role of 

genes, must be explored. 

Relevant to clinical research, we need to know the most efficient and cost effective way to diagnose and treat

patients with osteoporosis. While progress has been made to isolate certain risk factors such as race, smoking,

weight, family history of fractures, and previous fractures, further research is necessary to refine and clarify risk 

factors. In addition, more clinical studies on treatment measures, including exercise, must be conducted in order 

to better understand, prevent, diagnosis, and ultimately treat this complex disorder.

In behavior research, perhaps the most important progress we can make is in the behavior of children, adolescents, and young adults. We must learn to foster lifestyle behaviors that are conducive to healthy living, thereby

reducing bone loss. Adequate calcium intake, exercise, and healthy, smoke-free lifestyles must be fostered. Also, 

as women approach menopause, they should discuss the potential benefits and risks of estrogen replacement 

with their health care providers. 

The current biomedical and behavioral research for osteoporosis deserves much attention. If not provided, 

this disease will not only bankrupt our health care system, but the lives of million of women and men.

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Vice President for Women’s Healthcare

Clinical Research and Development

Michael J. Gast, M.D., Ph.D. Wyeth-Ayerst Research

Oral contraceptive and hormone replacement programs address a wide range of women’s health care issues.

With lower doses and changes in regimen, oral contraceptives have become safer over the years without a loss of 

efficacy. Noncontraceptive health benefits, including the prevention of sexually transmitted diseases, the lowering 

of the incidences of several of the reproductive cancers, and the prevention of a variety of medical conditions

requiring hospitalization of women have been additional benefits. Hormone replacement therapies (HRT) are 

being recognized in recent medical literature as providing superb global benefits for women’s health. 

Unmet health needs of women include infertility, endometriosis, uterine fibroids, reproductive cancers, depression, and collagen vascular disease. Wyeth-Ayerst has elected to refocus its own women’s health care research and

development activities with a capital investment of almost $35 million and the establishment of a Women’s Health

Research Institute devoted to the medical and social issues critical to female health. The Institute is devoted to 

the development of women’s health care medications. By removing the boundaries and integrating women’s health

research with the company’s other discovery efforts in areas such as heart disease, stroke, breast cancer, and Alzheimer’s disease, the company is able to leverage all of its resources to find solutions that benefit women’s health. 

With a primary focus on the definition of steroids, non-steroidal molecules and non-hormonal targets for the

treatment and prevention of women’s health disorders, Wyeth-Ayerst also supports other biomedical and behavioral

research issues in women. Improved screening techniques, important developments in chemical synthesis and 

molecular biology, and genetic techniques are helping to accelerate advances. Genomic technology in particular

holds the potential for uncovering the mechanisms of disease that underlie many women’s health disorders.

Wyeth-Ayerst recently funded a $16 million ancillary study to the Women’s Health Initiative (WHI) to evaluate the role of HRT in the prevention and treatment of Alzheimer’s disease, and is also providing Premarin and

Prempro to the 6-year “WHI Memory Study,” which involves 8,000 postmenopausal women age 65 and over.

Wyeth-Ayerst is also sponsoring the Heart and Estrogen-Progestin Replacement Study, known as HERS, a 5-year, 

$40-million, multicenter, placebo-controlled, double-blinded trial of the impact of HRT on approximately 

2,700 postmenopausal women with heart disease. 

In addition to its research program, Wyeth-Ayerst’s Women’s Health Research Institute will also disseminate

information about women’s health and support a wide variety of education programs aimed at both patients and

physicians. The benefits of HRT for protection against osteoporosis in women after menopause is one such area 

of education. 
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Associate Professor of Clinical Neurology

Arizona Health Science Center

Barbara S. Giesser, M.D. National Multiple Sclerosis Society

Sexual dimorphism in immune function is well documented. Female immune function is more vigorous than

that of men. Much of this distinction appears to be related to the most fundamental difference between the sexes:

the ability to conceive and bear children. A connection between the reproductive and immune systems has been

realized since the last century, although the complex network of interactions that are involved are only just now

beginning to be understood. Neural control is well established; however, it is becoming apparent that nervous 

and immune function do not operate in an isolated fashion, but are interdependent as well.

One of the most important connections between the nervous and immune systems is via the hypothalamic

pituitary adrenal (HPA) axis. Females of several species, including humans, have more HPA responsiveness than 

do males, and have higher cortisol levels in response to stress. Even at a basic level, there appear to be differences

between the sexes. HPA axis also demonstrates communication between the neural, endocrine, and immune 

systems, for example by regulating the immune cell number, activity, and production of cytokines. Cytokines, 

in addition to their principle activities of immunoregulation, can act directly on the hypothalamus to influence

release of hormone stimulating factors. Estrogen, progesterone, prolactin, and testosterone also have been shown 

to affect immune function. A third way in which the immune and neural systems communicate is via neurally

active substances that are produced by immune cells.

In contrast to relatively steady state immune function in men, marked fluctuations in immune status during 

a woman’s lifetime have been demonstrated. The most dramatic changes in female immunity occur during pregnancy, which is generally associated with suppression of cell mediated immunity, and normal or increased activity 

of humoral (antibody) immune responses. Clinical changes during pregnancy and postpartum are likely to be

mediated, at least in part, by the different concentrations of sex hormones. Premenopausal women undergo 

monthly metabolic and hormonal fluctuations, with immune function suppressed or enhanced coincident with 

different phases of the menstrual cycle. Many autoimmune diseases, neurologic autoimmune diseases, and nonimmune neurologic diseases are recognized to have symptom fluctuation coincident with menstrual cycle phases.

Changes in clinical status of women with autoimmune rheumatologic and endocrine diseases have been extensively documented, although less is known about autoimmune neurologic diseases, such as myasthenia gravis 

and multiple sclerosis, as a function of hormonal climate.

While it is clear that autoimmune disease predominates in women, the precise mechanisms by which this 

happens is unclear. Future research is recommended to fill the large gaps that exist in the understanding of autoimmunity, not only at a cellular and molecular level, but also as clinical phenomena, both in healthy persons 

and in persons with autoimmune disease. 

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Executive Director

Phyllis Greenberger, M.S.W. Society for the Advancement of Women’s Health Research

Gender-based biology — the examination of basic biological and physiological differences between men and

women — is the next frontier for women’s health research. This protocol has implications for disease research, 

clinical practice, disease prevention, medical education, and public health policy. 

It is a testament to those of us here that there is recognition of gender differences in disease manifestation. While we may continue to encounter skepticism on this, none of us doubt the reality and importance 

of gender differences.

There is increasing evidence to support the study of gender-based biology. Scientists have observed basic 

biological differences between the genders in areas of research as diverse as genetics, endocrinology and metabolism, cancer, and pharmacokinetics. These differences can significantly impact disease development and treatment. 

An organized and methodological approach to gender-based biology could promote better understanding of 

why gender differences exist and their implications.

Until recently, these discoveries were a by-product of other research. We need to create a system where such

observations are recorded and disseminated along with findings from more specific gender-based research studies.

We believe that the potential implications of gender-based biology are dramatic — for research, clinical practice,

disease prevention and manifestation, medical education, and public health policy. Issues associated with women’s

health represent the cutting edge of today’s knowledge and have the potential to dramatically change the way clinical medicine is conducted.

Mary Hammond, M.D. President, American Society for Reproductive Medicine

One of the greatest and most unfortunate gaps in the public’s knowledge about women’s health is a lack 

of understanding about human reproduction. Ignorance about human reproduction, whether willful or unintentional, is manifested in many ways, including unintended pregnancies, teen pregnancies, sexually transmitted 

diseases, and infertility. The unfortunate reality is that all these issues involve sex in some way, a public debate

about them becomes embroiled in debate about abortion. 

Many women’s health advocates outside the realm of reproductive medicine are reluctant to support reproductive health research because they wish to avoid the debate about abortion. This is evident in the ongoing ban of

federal funding for research using human embryos that remain after in vitro fertilization. Although the American

Society for Reproductive Medicine (ASRM) and the Association of American Medical Colleges enlisted an impressive group of supporters of embryo research, many large advocacy groups are reluctant to back such research

because of a fear that lending support would politically harm their own individual advocacy efforts. The Human
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Embryo Research Panel developed a set of ethically based and humane guidelines for the research. However, 

the guidelines received limited support from the President and were completely disregarded by the U.S. House 

of Representatives, which passed a complete funding ban on the research.

As plans are made for women’s health research in the next century, goals to fight attempts to politicize research

and rally women’s health advocates to support all promising basic and applied research rather than singling out

research that benefits a particular body part or condition should be included.

ASRM fears that federal support of contraceptive research and development may be the next casualty. Neither

public nor private support for this research has been strong. The enormous human and financial tolls of unplanned

pregnancy and STDs could be reduced significantly if women had access to a wider variety of contraceptives that

meet their family planning needs. The appalling lack of new contraceptive choices is a result of many factors,

including lack of contraceptive research support, liability fears of contraceptive manufacturers, and ideological 

conflicts. The recently released Institute of Medicine study, entitled “Contraceptive Research and Development:

Looking to the Future,” serves as a useful tool to navigate the issues surrounding contraceptive research and 

development. ASRM hopes that the Office of Research on Women’s Health will offer its strong support of embryo

research and contraceptive research and development and will work to de-politicize such important research.

Hazel J. Harper, D.D.S., M.P.H., F.A.C.D. President-Elect, National Dental Association

(Written testimony prepared by: Georgetta Manning-Cox, D.D.S., M.P.H., F.A.C.D., Howard University College 

of Dentistry; Hazel P. Haynes, D.M.D., University of Texas Health Sciences Center at San Antonio; Hazel J.

Harper, D.D.S., M.P.H., F.A.C.D.; Sheila S. Price, D.D.S., Ed.D., West Virginia University School of Dentistry;

Marilyn Woolfolk, D.D.S., M.P.H., University of Michigan School of Dentistry.) 

The special oral health needs of women that set them apart from men are greatly influenced by hormonal 

fluctuations, age, and stress. Factors that are age-related, gender-linked, or specifically problematic for minority

women include menopause, osteoporosis, diabetes, and stress. Oral manifestations during menopause are profoundly different from those during other phases of a woman’s life. Increased sex hormone levels correlate with

increased gingivitis and altered gingival inflammatory response. Other common complaints are pain, burning,

altered taste sensations, and xerostomia or dry mouth. Since women comprise 60 percent of the population age 

65 and older, the oral health needs of geriatric patients will most frequently be the needs of women, with women 

of low socioeconomic status and/or African Americans and other minorities at an even higher risk. Continuing

research on the role of estrogen in hormone replacement therapy in the oral health of menopausal and perimenopausal women is needed.

Oral bone loss can result from several systemic diseases and has been linked mainly with periodontitis or 

residual ridge resorption. Data suggests that older women are at risk for both osteoporosis and oral bone loss.

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Decrease of mandibular bone mass has been positively correlated with tooth loss in females. The role of osseointegrated implants to further retard bone loss in osteoporotic patients warrants further study. Preventive measures 

for osteoporosis include early identification of the risk factors, estrogen replacement therapy, calcium supplementation, and vitamin D. There is ongoing research on the therapeutic options of fluoride and the trace elements 

such as zinc, copper, and manganese for treatment and prevention of osteoporosis. 

Diabetes is the third-leading cause of death of among black Americans, especially among older black women;

other minorities have even higher rates. Uncontrolled diabetes can severely compromise oral health; changes

include cheilosis, burning sensation, decrease in salivary flow, alterations in the flora of the oral cavity, and

increased susceptibility to infection leading to destructive periodontal disease.

Additional research on the effects of specific combinations of vitamins used in conjunction with pharmacotherapeutics is needed.

Stress has been implicated in the etiology of periodontal disease. Oral manifestations of stress include painful

and recurring aphthous ulcers, gingivitis and bleeding gums, bruxism (grinding and clenching teeth), and temporomandibular disorders. Involuntary physiologic mechanisms that may induce stress-related periodontal disease

include impaired gingival circulation, lowered host resistance, decreased salivary flow, and endocrine imbalance.

The effects of stress and the role of vitamins, minerals (and herbs), and other nutritional variables on a woman’s

health cannot be overemphasized. 

Executive Committee Member

Council on Cardiovascular Disease in the Young

Laura L. Hayman, Ph.D., R.N. Council on Cardiovascular Nursing, American Heart Association

Cardiovascular diseases (CVD) are a major cause of disability and the number one cause of death in the 

United States, killing more than 954,000 Americans each year. Recent estimates by the National Center for Health

Statistics show that the number of deaths from CVD began to rise in 1993 after years of decline. More than one 

in four Americans suffer from some form of CVD at an estimated cost of $151 billion in 1996. CVD remains the

number one killer of females, and about 45 percent of female deaths in the United States are from CVD. CVD 

kills almost twice as many American females as all cancers, and five times as many females as breast cancer. 

Until recently, heart attack, stroke, and other cardiovascular diseases in women have not been recognized as 

serious health problems, particularly by women themselves. Despite the increasing attention to women’s health

issues, continuing and emerging gaps in knowledge about women and CVD must be addressed. Several examples 

of research studies that are needed to answer some of the most perplexing questions relevant to women and 

CVD are presented.
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These examples of research needs relate to: the interaction of sex hormones and specific risk factors for CVD 

and atherosclerosis; gender differences in the distribution of risk factors for coronary heart disease and stroke, 

levels of risk, and risk of disease at similar risk factor levels; the role of obesity and weight gain in CVD; the role 

of socioeconomic and psychosocial factors, as well as access to and quality of medical care, on CVD risk factors; 

the use of luteinizing hormone releasing hormone agonists and antagonists in the treatment of uterine fibroids; 

risk factors for and onset of stroke; the effect of autoimmune disease and inflammatory cytokines on the development of coronary heart disease, atherosclerosis, and heart muscle dysfunction; the relationship of diabetes and 

CVD status; and the apparent differences in presentation of CVD and response to intervention. Unique scientific

and logistical issues related primarily to hormonal differences, psychosocial variables, and possibly anatomical 

factors peculiar to women must be addressed in any randomized trial of CVD in women. 

The ability to combat CVD correlates directly with the level and quality of overall support for basic and 

clinical research and prevention efforts. Since 1949 the American Heart Association (AHA) has invested almost 

$1.4 billion in research to increase knowledge about CVD, making AHA second only to the National Institutes 

of Health in terms of financial commitment to cardiovascular research. The AHA will continue to commit increased

funding toward this research. However, a significant increase in funding for federal biomedical research is critical 

to win the battle against CVD. Chronic underfunding of heart and stroke research has also discouraged young 

people from entering this field of research. 

Chief, Sexually Transmitted Diseases Branch

Penelope J. Hitchcock, D.V.M. National Institute of Allergy and Infectious Diseases

Adolescent populations are at high risk of sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV) infection. In the United States it is estimated that 12 million incident cases of STDs

occurred in 1994; the majority of cases are in young adults, with an estimated 3 million occurring in teenagers.

Cases of gonorrhea are found among populations of low socioeconomic status (SES) in urban and rural areas.

Chlamydial infection is highest in 15 to 19 year olds regardless of SES. For the other viral STDs, the situation 

is similar to that for gonorrhea and chlamydial infection.

Using the framework of a mathematical model that considers how, why, and whether an infection spreads 

within a population, biological and behavioral risk factors/markers that alter the risk of STDs, particularly for 

adolescent populations, are reviewed. Within each factor of the equation there are risk factors that have been

causally associated with increased risk of transmission/acquisitions.

In terms of infectivity rate, the following factors represent increased risk for adolescents: genetic susceptibility,

sexual practices, age, age at first intercourse, contraceptive methods, alcohol use, drug use (intravenous and other),

smoking, and co-infections (STDs). For the rate of partner change and partner characteristics marker, the number 

of partners, type of partner, age, and age at first intercourse are factors that increase risk for adolescents. Host

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response, health care behaviors, routine screening, early diagnosis and prescription, prescription compliance, 

partner notification, and vaccine compliance are all increased risk factors associated with the duration of 

infection marker.

Currently, diseases such as syphilis, trichomoniasis, chancroid, HIV, and gonorrhea are concentrated in 

high-risk populations. Diseases such as chlamydial infection, genital herpes, and human papillomavirus infection are currently widespread, affecting the general population as well as the high-risk populations. Theoretically, 

as an incurable viral disease with an estimated 10-year incubation period, HIV infection is likely to “redistribute” 

over time, given that there is no biological reason for it to be confined to high-risk populations.

The risk factors/markers identified represent a formidable research agenda that includes basic biomedical 

and behavioral research, applied research, and clinical and operations research. More support for clinical services 

for adolescents in a variety of settings is implicit in an effective approach to prevention and control. 

Senior Public Policy Associate

Lisa Kaeser, J.D. Alan Guttmacher Institute

The Alan Guttmacher Institute is a not-for-profit public education and public policy organization that 

focuses on reproductive health. This testimony addresses the needs in one area of reproductive health, that 

of further research into successful use of contraceptive methods to prevent unintended pregnancy.

An increasingly greater portion of women’s lives is spent attempting to control their fertility. During the 

last century, both puberty and sexual initiation have moved to earlier ages. The interval for women between 

puberty and marriage has risen and most married women choose to delay or limit the number of children they 

have. Women today spend three-quarters of their reproductive lives from menarche to menopause trying to 

avoid becoming pregnant.

Unintended pregnancies, and their outcomes, carry significant health and social consequences for both the

woman and, if she carries to term, the child. However, in 1988, more than 3 million unintended pregnancies

occurred in the United States. If contraceptives were always used perfectly by everyone who wanted to avoid

becoming pregnant, the rates of unintended pregnancy in the United States would be a fraction of where they 

now stand. Current wisdom, which provides a major rationale for continued research on new contraceptives, 

points to difficulties women and men have integrating correct and consistent use of current methods into their

daily lives. Clearly, a better understanding of the needs of women and their partners who wish to use contraception is needed, both to increase the use of currently available methods and for the development of new ones.

Specifically, a better understanding is needed of what causes people (1) to delay initiating use of a contraceptive method once they become sexually active, (2) to permit gaps between periods of contraception use, 

or (3) not to use their chosen method as well as possible. 
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Obstacles that may prevent couples from using contraceptives when they are at risk for unplanned pregnancy include: (1) women not initiating the use of or stopping the use of contraceptives due to a lack of accurate information or fear of side effects, and (2) access to and payment for family planning services. Research is 

needed on what may contribute to using contraceptives. Such research may focus on: a woman’s ambivalence 

about childbearing, common mistakes in the use of contraceptives, concerns about disease that prevent women 

from using the most effective contraceptive method(s), and the impact of education and counseling on the 

successful use of contraception. 

Although contraceptives have been used for decades, many questions remain unanswered. While answers 

to these questions will not necessarily “solve” the dilemma of unintended pregnancy in the United States, if the

answers can assist in reducing the rates of unintended pregnancy, a substantive contribution to women’s health 

can be made.

Executive Director

Virginia T. Ladd, R.T. American Autoimmune Related Diseases Association

Autoimmunity is a debilitating condition in which the immune system attacks the body’s own tissues or 

cells. The condition is the root cause of more than 80 serious and chronic diseases, including connective tissue 

diseases (lupus); diseases involving the joints (rheumatoid arthritis); skin diseases (scleroderma); neuromuscular

diseases (multiple sclerosis); and endocrine diseases (Graves disease). The American Autoimmune Related Diseases

Association (AARDA) is the nation’s only organization dedicated to raising the awareness of early warning signs 

of autoimmune diseases and promoting collaborative research efforts to cure autoimmunity.

During its recent Health Women 2000 conference in Washington, the Office of Research on Women’s Health

recognized that autoimmunity is largely a women’s health problem, representing approximately 75 percent of all

autoimmune patients. ORWH has a great opportunity to increase the visibility and focus on autoimmunity as a

common cause of diseases that disproportionately affect women. 

For many women, getting a proper diagnosis for an autoimmune disorder is as difficult as the disease itself.

Misdiagnosis and late diagnosis and their associated problems are major concerns of AARDA. Several factors contribute to improper diagnosis, which delays appropriate treatment. For instance, symptoms of autoimmunity vary

and they may come and go. Also, symptoms are often difficult for a woman to describe precisely to her physician.

The multiplicity of symptoms and affected body systems may cause the patient to undergo a series of unsuccessful

tests as specialists attempt to establish a diagnosis. The difficulty in identifying symptoms may result in a physician

not taking the patient’s complaints seriously. A survey AARDA conducted found that over 65 percent of patients

with autoimmune diseases are labeled hypochondriacs in the earliest stages of their illness. The psychological

impact of late diagnosis can be devastating.

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The problems of timely recognition and diagnosis results from the fragmented way in which the medical 

community approaches autoimmunity. Unlike cancer, autoimmunity has yet to be embraced by the medical community as a category of disease. Discovering the root cause for all autoimmune diseases depends on basic research.

ORWH is well-positioned to take a leading role in organizing a concerted education and research campaign to

improve recognition of and early testing for autoimmune diseases and in promoting basic research into autoimmunity. Basic research will yield information that benefits the treatment and diagnosis of all autoimmune 

diseases and represents the most promising approach to finding a cure.

The AARDA desperately seeks to bring a national focus to autoimmunity. We feel that ORWH, perhaps 

more than any other office or institution, can substantially improve our country’s approach to this critical women’s

health issue. We strongly urge ORWH to push for collaborative efforts to conduct basic research that would bear 

fruit for all autoimmune diseases, rather than continuing to focus more narrowly on individual diseases. Through

combined research we will be able to diagnosis, treat, and ultimately cure this debilitating disorder.

Dorothy Mann Executive Director, Family Planning Council

The Family Planning Council is a private, nonprofit organization which receives all Title X federal family 

planning funds for Philadelphia and its four surrounding counties. With these and other public funds, the Council

subcontracts with 24 local health care organizations. The typical Title X family planning patient seen in any one of 

our programs is an African-American woman between the ages of 20 and 29. She is poor, and the family planning

clinic offers the basic health care she needs to stay in school, keep a job, or pursue vocational training.

Gaps in knowledge about women’s health involves reproductive issues. Specifically, the need for knowledge 

is greatest in the areas of pregnancy and disease prevention. According to the Institute of Medicine, the rate of

unintended pregnancy among American women is disgracefully high, with almost 60 percent of all pregnancies

unintended. Regardless of a woman’s economic level, unintended pregnancy affects every sphere of a woman’s life,

threatening her physical well being, her emotional stability, and her ability to obtain or keep gainful employment.

The high rate of unintended pregnancy among American women should be a clarion call to the health care and

medical research establishments and the pharmaceutical companies to devote the resources necessary to significantly reduce this statistic. Contraceptive research is needed to find methods that offer the full range of protection

against unplanned, unwanted pregnancy as well as debilitating, highly contagious diseases.

A number of other questions also have important implications for women’s health. These questions relate to

HIV/AIDS; the reproductive health care needs of premenopausal, perimenopausal, and postmenopausal women;

risks for unintended pregnancy, sexually transmitted diseases; cancer; education about the use of hormone replacement therapy; and infant mortality among African Americans.
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Unlike with research and medical service delivery for cardiovascular disorders, breast cancer, endocrine disorders, and Alzheimer’s disease, Congress dictates the methodology, scope of research, and medical procedures in the

area of reproductive medicine. Currently, Congress is considering legislation that will require the written consent 

of parents for any research that involves adolescents. Although strict consent requirements and protection of human

subject regulations exist, Congress wants to curtail research that examines any research related to adolescent sexual

health. In this way a political agenda takes precedence over the quest for knowledge and understanding. It is easier

to allocate public and private resources to politically palatable research in such areas as breast cancer and osteoporosis than it is to devote the necessary resources to other equally important areas of women’s health that are related 

to sexuality. While adding women to clinical trials and other research efforts is necessary and important, it will not

matter if political agendas dictate subject, method, and outcome. In women’s health research, it is important to

invest in and examine controversial issues of sexuality and reproduction. It will take courage to expose and 

stand up to powerful political forces that would otherwise impede this research.

Executive Director

Rita M. May Sjögren’s Syndrome Foundation, Inc.

Autoimmune and rheumatoid diseases are the stepchildren of the women’s health initiative. Despite the 

fact that diseases such as multiple sclerosis, scleroderma, and Sjögren’s syndrome profoundly affect women, 

they are not considered topics of high priority on any of the women’s health agendas.

Medicine and science favor the so-called “interesting questions.” They attract the greatest scientific intellects,

are well funded, and reflect social priorities. For example, AIDS, a comparatively rare disorder, was successfully

transformed from an interesting scientific problem into a well-funded institution. During the 14-year period from

1981 to 1995, about a half-million Americans were diagnosed with AIDS compared to more than 37 million Americans who suffered from other autoimmune diseases. The drive to find a cure for AIDS has made NIAID the third

most heavily funded NIH institute, while funding for more widespread autoimmune diseases has declined.

Probable reasons for the lack of interest and minimal funding include the following:

• The sheer number of autoimmune diseases and the dearth of clear diagnostic guidelines

• The association of autoimmune diseases with aging but not death, and the subsequent lack of 

urgency to discover treatments and cures

• The higher prevalence of autoimmune disease among women than men

Sjögren’s syndrome presents an excellent example of the ignorance, invisibility, and unpopular nature of

autoimmune and rheumatoid diseases in general, and within the scientific and women’s health communities 

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in particular. Although it affects 2 to 4 million Americans — 90 percent of whom are women — it is one of 

the least diagnosed. Moreover, none of the most likely NIH institutes — NIAMS, NIAID, NEI, nor NIDR — 

has sponsored epidemiological studies directed at Sjögren’s syndrome. Indeed, the chances for even highly 

sophisticated audiences to have heard of Sjögren’s (much less be able to spell it!) are low, sadly demonstrating 

the lack of interest in these diseases and in the women who suffer from them.

I ask that NIH dedicate research monies to autoimmune disease research and conditions affecting the 

aging as well as diseases affecting reproductive issues and youth.

Margaret K. McLaughlin, Ph.D. Magee-Women’s Research Institute

At the Magee-Women’s Research Institute, we believe that increasing the number of women scientists and 

facilitating their careers will result in more women’s health researchers. This task requires a concentrated effort 

to increase public awareness about the significance of scientific research. We believe that our outreach work will

result in greater awareness of and interest in science and research on women’s health. Our efforts target high school

and college students — both boys and girls, men and women. We host tours of the Institute, provide hands-on

demonstrations of our work, sponsor a summer research volunteer program, and provide stipends for college students studying the sciences. Some programs we target directly at young women. For example, we have a special

relationship with a local girls’ high school and pay special attention to women’s colleges in our geographic area.

At a more advanced level, we recognize that nursing is a severely underutilized source of women in science.

The Institute pays part of the salary for the director of nursing research at Magee-Women’s Hospital, where she 

educates nursing staff about research opportunities and recruits participants for Research Institute projects.

Retention, as well as recruitment, is critical to ensuring there are women in science. We feel that it is important to not lose sight of the problems that face men and women embarking on careers in scientific research. It 

is critical that they understand the gender issues in research and are supported in their efforts to advance in the

areas in which they choose to specialize. Our proactive mentoring program is a crucial tool for assisting new

researchers in overcoming these challenges and encouraging them to remain in the field.

We are proud of these efforts and hope others can learn from them in their quest to demonstrate and 

increase public awareness about the joys and excitement of careers in science.
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Associate Medical Director and Professor of Pathology and Laboratory Medicine

Allegheny University Hospital

Powers Peterson, M.D. American Society of Clinical Pathologists

New developments in the area of women’s disease research and diagnosis as well as the increased participation of women in biomedical careers have been encouraging. However, more needs to be done if progress 

in the field of women’s health is to continue successfully into the 21st century.

Women currently comprise a large sector of the health care community. In 1994, women represented 18 

percent of all physicians in the U.S. In the field of pathology, women comprised 24 percent of all pathologists 

in the country and 83 percent of the medical technologists certified by ASCP in 1995. 

ASCP has been indirectly involved in efforts to recruit, retain and advance women in biomedical careers 

on a project-to-project basis. ASCP volunteers have been involved with educational projects, funded through 

the Title VII Allied Health Project Grant Program, designed to enhance recruitment and retention of minority 

and disadvantaged populations. One model program utilizes the mentor concept and promotes the recruitment 

and retention of medical technologists through a four phase design that begins with career awareness activities 

for elementary and middle school students. Similar projects could be established for the recruitment and retention of women in biomedical careers.

Offices of Women in Health Professions on some medical school campuses provide another successful model.

These offices serve as excellent resource centers and bring together a variety of health care providers, both physician and non-physician, to address issues related to women in biomedical careers. In addition, ASCP offers print

and video materials describing careers in laboratory medicine; maintains a scholarship fund for individuals wishing 

to pursue such careers; and has a Career Recruitment Network, which provides mentors for those seeking to 

enter the field of laboratory medicine.

Although progress in addressing women’s health issues is being made, a stronger infrastructure needs to 

be established to identify and respond to new challenges for women’s health. Adequate funding is imperative to

explore further and better understand the implications for women regarding new advances in disease research 

in the areas of cancer, heart disease, and HIV and other infectious diseases. In particular, more must be done to

research further and investigate various aspects of women’s health and coronary heart disease. In addition, women’s

health care could be served better as a comprehensive discipline that uses a combination of medical perspectives 

in patient care. The future of women’s health research also needs to include a focus on emerging infectious diseases

including chlamydia, sexually transmitted human papillomavirus, and Group B Streptococcus. Despite the continued threat of emerging infections, support for applied research and control efforts has declined during the 

past decade. For this reason, it is critical that women’s health research, and the resources to conduct such 

research, focus on addressing emerging infectious diseases.

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Health Policy Consultant

Marj Plumb, M.N.A. National Center for Lesbian Rights

The Lesbian Health Project of the National Center for Lesbian Rights supports grassroots organizing and 

advocates for equitable public policies regarding health care for lesbians. The purpose of this testimony is to 

begin to articulate a common understanding of what lesbian health issues are, to share the successes of the 

modern lesbian health movement, and to present a universal list of recommendations that can be enacted by 

public health departments, health agencies, research institutions, and medical schools. The lesbian community 

is more interested in health issues than ever before, is more knowledgeable about the health care system and 

health terminology, and has greater access to the federal health department than under any other administration.

Grassroots groups have developed and implemented lesbian and bisexual women’s health needs assessments 

and have begun strategic planning for program development in many communities.

Lesbians and other women who partner with women have unique health concerns which often go unaddressed 

in a medical setting which generally assumes heterosexuality. Specific issues include cancer screening, sexually

transmitted diseases, HIV, depression, substance abuse, relationship issues, aging, pregnancy, and parenting. 

Among the most significant health issues for lesbian and bisexual women is lack of access to sensitive medical 

services. This lack of access may result in lesbians avoiding care until forced to do so by the severity of their 

symptoms; delay in diagnosis and treatment may result in poorer health outcomes for the population. 

Researchers face numerous difficulties in studying the lesbian population, thus complicating the ability to 

present health status information about this population. Among these difficulties is the challenge of obtaining 

random samples and women’s reluctance to disclose their sexual orientation or the gender of current or past 

sexual partners. Specific points for consideration in developing future research activities are presented.

Numerous national organizations and projects have been formed to address specific health care needs and are

potential sources for researchers to gain technical assistance and access to lesbian research subjects. Recent efforts 

by the U.S. Department of Health and Human Services to include lesbian and bisexual women’s health issues in

programs, conferences, and written materials are described; these efforts represent significant advancements in 

lesbian access to the federal public health department. The testimony outlines recommended efforts within the 

federal, state, and local health systems, as well as within the private sector to ensure the widest access to information, services, and research for lesbians, bisexual women, and all women who partner with other women. 

Specific recommendations are made in the following areas: conducting research, providing services for the 

prevention and treatment of disease, educating and informing the public, recruiting and training health care 

personnel, and designing guidance on lesbian and bisexual women’s health initiatives.
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Linda Quander, Ph.D. Associate Professor, Clark Atlanta University

Strategic management is a process which requires planners and decisionmakers to accomplish eight key tasks:

• Clarify purpose

• Select goals and objectives

• Identify present strengths and weaknesses

• Analyze future opportunities and threats

• Compare strengths and weaknesses to opportunities and threats

• Decide on long-term strategy

• Implement the strategy

• Evaluate the strategy

Women’s health researchers must learn to anticipate rapid changes that affect their projects, working groups,

organizations, and even their careers. Conferences — such as this one — can facilitate this by basing training, 

education, and development on projected future needs. 

Needs assessment is critical for identifying learning gaps and discovering weaknesses. It is part of the process

in which we ascertain future needs relative to overall performance in women’s health care. Therefore, effective communication about needs assessment is paramount in designing, implementing, and interpreting research programs.

Researchers must be aware of how communication can ultimately enhance or adversely affect women’s health.

NIH and the National Institute of Environmental Health Sciences are to be commended for recognizing that

scientific knowledge, combined with effective communications, can empower women to better control their personal environments and thus improve their overall health. I am particularly enthusiastic about NIH’s Women’s

Health Initiative, an important study of strategies that can enhance adoption of healthy behaviors by using a 

multidisciplinary approach in cooperation with various community-based prevention centers.

Researchers need to analyze various types of traditional and nontraditional channels. For example, studies 

of African-American women have found that churches are a particularly useful route. We now know that it is

important to understand how and why community-based prevention centers appear to be effective in reaching

minority populations.

Communication channels to women must be future-oriented and proactive. Strategies need to see women 

as active, adaptive team members, not as passive obstacles to progress. Cooperative partnerships are effective 

tools for addressing inequality in health care for women and reaching women throughout the community.

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James M. Roberts, M.D. President, Society for Gynecological Investigation

One of the refreshing aspects of the increased emphasis on women’s health research attributable to the

Women’s Health Initiative is the heightened awareness that women’s health is not limited to reproductive health.

Research has shown that there are gender differences in many aspects of health and medicine, and recognition of

this phenomenon has led to changes in how women are treated for illnesses not directly related to their gender.

Indeed, we are now seeing improvements in female morbidity and mortality statistics that reflect this revision 

in medical approaches and attitudes toward female patients.

It is now generally recognized that many diseases manifest themselves differently in women than in men.

Women face different cardiovascular risks than men, which has certain implications for diagnosis. Similarly, 

women appear to be more susceptible than men to illnesses such as autoimmune disease, and we now know 

that women metabolize drugs differently than men.

Of course, we should not abandon research on reproductive health. Reproductive health statistics such 

as premature births remain alarmingly high, particularly in disadvantaged populations. Likewise, death from

preeclampsia — a condition recognized for more than 1,000 years — is the highest cause of maternal death 

in developed countries. Death rates also remain high for infants of preeclamptic women.

Research in these areas has led to many exciting discoveries with important treatment possibilities for 

genetic ailments. New findings in molecular biology and our ability to handle data more effectively provide 

us with opportunities to solve major problems that have affected women and infants. 

We must also ensure that researchers interested in women’s health are nurtured and supported throughout

their academic and professional careers. Money for training — both federal and private — is extremely important.

Still, our most valuable resource is the cadre of talented individuals embarking on scientific careers, including 

the generation of future scientists now in grade school. 

In this time of restricted resources and academic upheaval, we must resist the urge to complain that things 

are worse than ever. We must “hang tough” and remember the importance of our goal. We must convey to our

young successors the rewards, excitement, and vital importance of research relevant to women’s health.
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Assistant Professor of Clinical Medicine and 

Associate Director of Nuclear Cardiology, Columbia University

Roxanne A. Rodney, M.D. Association of Black Cardiologists

(Testimony prepared by the Association’s Committee on Cardiovascular Diseases in African-American Women:

Sheila A. Robinson, M.D.; Hannah A. Valantine, M.D.; Jan D. Webber, M.D.; Roxanne A. Rodney, M.D.)

Coronary heart disease is the number one killer of American women, and African-American women are 

disproportionately affected. In 1992, the death rate from coronary heart disease was 32.6 percent higher in 

African-American women than in Caucasian women. It has also been reported that black women’s rate of 

mortality following heart attack is higher than that of white women, black men, and white men. 

Black women also have the highest estimated crude prevalence of stroke, and the mortality rate from stroke 

in black women is 77 percent higher than that in white women. Hypertension is also more prevalent in AfricanAmerican women ages 30 to 39 and ages 60 to 69, compared to Caucasian women and Mexican-American women 

in the same age groups. The mortality rate due to hypertension is also higher in women than men (58 percent 

vs. 42 percent, respectively). African-American women are also more likely to have risk factors for CVD. 

Risk factors discussed are hypercholesterolemia, diabetes, smoking, physical inactivity, and overweight.

The Association of Black Cardiologists unequivocally supports increased funding of clinical and basic science

research in cardiovascular diseases in African-American women. Women in general, and African-American women

in particular, have been underrepresented in research studies. However, in order to obtain accurate data on at-risk

populations, these groups must be included in research studies. The Association also promotes the provision of

educational programs for at-risk populations. Such programs should address primary disease prevention through

risk factor modification and should emphasize the importance of seeking early, appropriate care if symptoms are

present in order to reduce the incidence of secondary complications. Coupled with this, health care providers 

must continually be educated about the prevention, timely diagnosis, and appropriate treatment of cardiovascular diseases in black women. 

In addition to the immeasurable impact of cardiovascular morbidity and mortality on the lives of AfricanAmerican women and their families, the societal impact in terms of lost productivity and health care expenditure

cannot be understated. Health care dollars are more effectively utilized in the generation of accurate research data,

which can then be appropriately implemented via the education of at-risk groups and health care providers. This

strategy is medically appropriate and cost effective.

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Professor of Health Education and Women’s Studies

Sheryl Burt Ruzek, Ph.D., M.P.H. Temple University

The national women’s health research agenda should be refocused to address: (1) the prerequisites to women’s

health that are ignored in a narrow biomedical paradigm; (2) pressing issues in social and behavioral paradigms;

and (3) ignored or suppressed research questions grounded in mind/body, alternative, and folk healing traditions.

This testimony reflects disquietude with the definition of women’s health that is used widely in government and

medicine. This narrowly biomedical definition, which focuses on diseases or “conditions” in women, institutionalizes expectations and collective demands for biomedical interventions at a time when access to medical care is 

particularly problematic. It may be preferable to adopt research priorities that reflect the vision of health that the

World Health Organization promotes as “a state of complete physical, mental, and social well being and not merely

the absence of disease or infirmity.” The definition outlines a number of “prerequisites for health,” which have

important gender dimensions and raise critical issues about social class and culture in the production of health. 

A women’s health agenda might profitably build on National Center for Health Statistics reports of a clear 

gradient in mortality both for white women and women of all races by educational attainment. The inclusion 

of education as a research variable would help interpret findings that are reported by race or ethnic group. 

More attention needs to be paid to health status differences among women within racial/ethnic groups.

Emerging mind/body models that emphasize psychological and spiritual dimensions of health seem particularly invisible in federal agendas for women’s health. More research is needed on how women’s health needs 

are addressed in traditional, non-western healing systems that posit spiritual and psychological dimensions of

health. However, mind-body paradigms pose a “double-edged sword” for many women in that psychogenesis, 

in the past, has been used against women by physicians. Important relational concepts such as caring also 

deserve more recognition. 

Theoretical and conceptual work is needed to link empirical research areas to one another. Integrative 

models are needed to understand how working and living conditions, individual health behaviors, psychological and emotional processes, and effective biomedical interventions together contribute to health and 

well being. Women’s health research must also explicitly take into account the health of significant others, 

including men, children, parents, and life partners. 

Many questions deserve attention in a broader framework for understanding women’s health. These questions

relate to: the cultural relevance and appropriateness of services; links between race/ethnicity, socioeconomic status, 

and the cultural context of health practices and the availability of health services; the ways in which women in 

different life situations view and make decisions about health, disease, and health-related issues; utilization of 

traditional healers and other less conventional therapies; social and environmental factors in diverse groups; 

and research-content decisionmaking.
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Dean for Faculty Affairs

Eleanor G. Shore, M.D., M.P.H. Harvard Medical School

The representation of women at Harvard Medical School (HMS) and Harvard School of Dental Medicine

(HSDM) in 1996 range from a high of 49 percent for students to a low of 7 percent for the rank of Professor. 

At the student, trainee (clinical or research fellow), and instructor levels, representation is consistent with or 

better than the availability pool; however, at the voting faculty ranks (Assistant Professor and higher), the percentages reflect a critical problem. Even among those women already appointed as Instructors or Assistant 

Professors, a smaller percentage are promoted over a 10-year period than their male colleagues.

The Office for Faculty Affairs has launched a number of interventions to try to correct this gender gap including the establishment of appointment procedures designed to assure that new faculty positions are accessible to 

all qualified candidates; the requirement for formal annual career conferences for women and underrepresented

minorities to assist in career planning and direction; and career assistance by conferences, workshops, and ad hoc

individual counseling for trainees and junior faculty through the Office for Academic Careers, Minority Faculty

Development Program, Women in Academic Medicine Program, and the Office for Faculty Affairs.

The most serious problem faced by women in their academic careers is demonstrating independent academic productivity (research, teaching, grant application, and paper writing) because of a lack of sufficient 

protected time for these activities. Without substantial tangible evidence of academic creativity, promotion 

comes more slowly, if at all. The 50th Anniversary Program for Scholars in Medicine provides for ten fellowships a year for women or men who can demonstrate both great academic promise and complicating personal 

responsibilities which might be remedied by a grant of $25,000. In the first competition, more than 210 

women and men applied for the ten fellowships. 

A similar set of national fellowships could make a large difference in diminishing the gender gap. Given 

the challenges in the biomedical field for the 21st century and the fact that more than half of the students in 

science and medicine at HMS are women, there is every incentive to support these women through the hardest time in their professional lives. Men qualify for the great majority of sabbaticals at HMS since they occupy 

93 percent of the senior positions that are covered by the University’s sabbatical policy. It seems only fair that 

institutional resources be directed at an earlier point in women’s careers when the need is greatest, rather 

than saving the support for a sabbatical that few women will ever reach without this additional help earlier 

in their careers. 

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Founding President

Martha Torres-Montoya, M.S.P.H. Hispanic Women’s Health Association

Research into the health needs of Hispanic/Latina women is very limited at present. Notably meager are epidemiological data, program evaluation models, effective interventions, and clinical trials. Where such research

exists, it generally focuses on issues of access — health insurance, geographic, language, and cultural barriers.

As a result, little is known about Hispanic/Latina women’s health issues and status. The inability to describe 

the problems or document the needs has put these communities in a poor position to obtain government funding.

This lack of original research has seriously impeded health service agencies and community-based organizations

from addressing gaps in health care for Hispanic/Latina women. Until and unless community-based agencies are

able to document health and social problems affecting Hispanic/Latina women, federal funds are unlikely to be

forthcoming. The result is poor, ineffective health care policies that, in turn, impact the availability, distribution,

and utilization of scarce health care dollars.

The Hispanic Women’s Health Association (HWHA) has a strong commitment to developing and implementing successful research projects in the Hispanic community. We recommend that ORWH conduct research into 

the following areas of importance to Hispanic/Latina women:

• Differences in health perceptions, physical and mental health, and social support systems;

• Impact of welfare reform;

• Impact of acculturation on health status;

• Health beliefs and practices;

• Preconceptional health issues for use in a national campaign;

• Infertility;

• Depression, cultural perceptions, and coping strategies;

• Interventions to reduce teen pregnancy;

• Interventions that encourage men to become involved in family planning;

• Alcohol use/non-use; and

• Patterns of family formation.

The HWHA also urged ORWH to revisit the recommendations made for Hispanic/Latina women 

in 1991. They requested that ORWH prepare a report that describes how those recommendations were 

implemented in the past 5 years and/or how they could be integrated into the 1996 agenda.
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Laura L. Tosi, M.D. American Academy of Orthopaedic Surgeons

Women are far more prone than men to hip fractures and bone-related diseases such as osteoporosis, 

and their susceptibility increases with age. The associated loss of life and suffering involved in fracture and 

disease is enormous, as are the medical bills, which approach $10 billion each year.

As a mender of broken bones, the American Academy of Orthopaedic Surgeons (AAOS) is deeply concerned 

that nearly 300,000 individuals will suffer hip fractures this year and that women’s fractures will outnumber 

men’s by almost 3 to 1. In addition, women over age 65 have a 1-in-5 chance of suffering a hip fracture 

during their lifetimes.

These statistics demonstrate the importance of early intervention in reducing the prevalence of osteoporosis.

Since many orthopaedic injuries are preventable, early intervention provides the greatest potential for reducing the

numbers. As such, education and intervention must begin in childhood. Although evidence shows that increasing

calcium intake during adolescence is critical in the development of peak bone mass and growth, there is a desperate need for longer, prospective trials. We need data confirming the current actual intake of calcium in our young

people. We also need to determine how we can encourage young people to alter their dietary lifestyles.

While the Academy is concerned with osteoporosis and resultant injuries, we are also interested in the incidence of sports injuries in young female athletes. Athletes and their coaches need to be instructed more effectively

about the orthopaedic risks associated with playing sports. Investigation into the increased risk of knee injury in

young female athletes as opposed to young male athletes in also essential. Strengthening strategies and training

techniques must be explored at every level so that injuries can be prevented.

For many years, AAOS has devoted tremendous energy to osteoporosis research and injury prevention such as

our campaign called “Live it Safe,” which we sponsored with the American Association of Retired Persons. Although

we believe these programs are effective, our own goals are to expand these efforts so that we can better understand

the needs of young women and design effective educational strategies to improve their health habits.

The Academy commends the Office of Research on Women’s Health for its extensive work in encouraging

research on solutions to women’s health problems, such as osteoporosis. We believe the Office of Research on

Women’s Health can and should play a leadership role in identifying the key cause and effect relationships of 

osteoporosis. The cost of education, intervention, prevention, and rehabilitation amounts to several billion 

dollars a year. Nevertheless, the improved quality of life is incalculable.

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Gastroenterology Women’s Coalition

(Representing the American Gastroenterological Association 

American Society for Gastrointestinal Endoscopy 

American Association for the Study of Liver Diseases 

Jacqueline Lee Wolf, M.D. and American College of Gastroenterology)

Colorectal cancer is the second deadliest cancer in the United States and the third leading cause of cancerrelated death in women. Women with hereditary colon cancer are at increased risk of ovarian and endometrial 

cancers. Further study of colon cancer in women may provide important information on the etiology of these 

associated cancers. Also, further research is needed on how gender and knowledge of genetic status affect 

screening participation.

Basic and clinical research is needed on the pathogenesis, immunology, and therapeutic approach to primary biliary cirrhosis, a disease nine times more common in women than in men. Among the additional aspects 

of liver disease in women that merit expanded study are: the impact of sex hormones on elements of the immune 

system and on the proliferation of liver cells; the factors responsible for differences between men and women 

in alcohol absorption and metabolism; and the effects of estrogen and progesterone on the development of 

alcoholic liver disease. 

The Helicobacter pylori bacterium is a relatively new discovery that has revolutionized and advanced treatment for peptic ulcer disease. Studies show that H. pylori-infected women are 15 to 18 times more likely to develop

gastric cancer than infected men. Further research is needed on the role of acid secretion in protecting against the

development of gastric cancer and on clinical approaches to preventing gastric cancer. Research on the prevention 

of peptic ulcer disease induced by non-steroidal anti-inflammatory drugs (e.g., aspirin and ibuprofen) is needed. 

Gallbladder and biliary tract disease are twice as common in women as men. The role of estrogens and progesterones in the formation of gallstones particularly during and immediately following pregnancy; the basic 

biology of gallstone formation, and potential preventive measures merit further study.

Irritable bowel syndrome and functional bowel disorders are twice as common in women as men. Additional

research is needed on the effect of the menstrual cycle on functional bowel disorders; and the relative impact of

genetics, the environment, and social factors on the etiology and perpetuation of symptoms. 

Aside from research priority objectives, the Coalition recommends the following mechanisms for enhancing

biomedical research career opportunities for women: NIH should expand small grant support for mentoring programs for women; NIH should provide seed money for the initiation of special academic tracks for women interested in research careers; academic institutions should be encouraged to adopt “stop the clock” policies with regard 

to tenure and promotion of women faculty; NIH should allow institutions to include in their indirect cost calculations, programs to prepare women faculty members for senior administrative positions (departmental chairs or

deans) through which they can continue to foster research and influence the research activities of their institutions. 
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Elizabeth Yoffe, M.A. Self

Conventional medicine is a wonderful, lifesaving, and life-enhancing tool. However, its long monopoly in 

the overall health care picture is beginning to loosen as laypeople, insurance companies, and even parts of the 

medical establishment recognize that alternative therapies can complement conventional medicine.

My interest in the health care system was sparked after I suffered a crippling stroke at the age of 30. Conventional medicine and rehabilitative therapy literally got me back on my feet, but their value in the recovery process

was limited. To improve my physical functioning, I turned to alternative healing methods: meditation, relaxation

techniques, and visualization. I became more intrigued by what was then called “unconventional medicine” and 

set out to learn more about alternative modalities.

Today, more people — especially women like me — are questioning the existing medical system, taking control and responsibility for their health, and exploring alternative treatments for chronic or degenerative illnesses. 

However, resistance to alternative healing persists, particularly from conventional practitioners. 

There are interesting links between the emerging fields of women’s health and alternative medicine. Both are

regarded as outside the medical norm. The same can be said about medical practices that originate in China and

India, which are far older and more refined than Western medicine. There seems to be an assumption that only

medicine developed from a Western cultural perspective is “real.” Other medical traditions are regarded as backward or primitive. Alternative medicine may receive more acceptance from women patients and health practitioners because, historically, women have a deep bond with natural or folk remedies.

It is ridiculous to deny people education about and access to alternative therapies that might help them 

recover or better manage illness. I recommend the following four steps:

• Increase cooperation between the Office of Research on Women’s Health and the new Office 

of Alternative Medicine (OAM);

• Integrate findings from OAM into public health education programs;

• Integrate alternative medical modalities in medical schools; and

• Increase communication between conventional and alternative medical professionals.

Neither conventional (i.e., Western) medicine nor alternative medicine can cure all our ills. However, now 

that we have access to therapeutic modalities from different cultures and philosophies, it is the responsibility 

of all medical practitioners to work together to improve on what we have today. 

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Gerald S. Berenson, M.D.

Tulane Center for Cardiovascular Health

James E. Dill, M.D., F.A.C.P.

Endoscopic Ultrasound of Virginia

Carolyn Evans, M.S.W.

Grace House of New Orleans, Inc.

Wonda L. Fontenot, Ph.D.

Wannamuse Research Institute

Julie E. Goslee, Pharm.D.

Xavier University of Louisiana

Alton E. Hadley

Louisiana Department of Health and Hospitals 

Saletta A. Holloway

Meharry Medical College

Marlene Keeling, B.S.B.A.

CANDO (Chemically Associated 

Neurological Disorders)

Judith H. LaRosa, Ph.D., R.N., F.A.A.N.

Tulane University School of Public Health 

and Tropical Medicine

Marva L. Lewis, Ph.D.

Self

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PUBLIC TESTIMONY

NEW ORLEANS, LOUISIANA 

JUNE 11, 1997

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Jennifer C. Lovejoy, Ph.D.

Pennington Biomedical Research Center

Frances J. Mather, Ph.D.

Tulane University

Danita M. Muse, M.S.W.

Women With A Vision, Inc.

Marcy Ouellette, M.D., M.P.H., T.M.

Louisiana Office of Public Health

Eileen M. Palace, Ph.D.

The Center for Sexual Health 

Tulane University Medical Center

Jayashree Rao, M.D.

Self

Meghan-Morgan Shannon, M.S.

Medical Professionals with CFIDS/CFS/ME

Amanda Sherman

DES Action USA

Denese O. Shervington, M.D., M.P.H.

Institute of Women and Ethnic Studies
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Gerald S. Berenson, M.D. Director, Tulane Center for Cardiovascular Health

Heart disease is the major cause of morbidity and mortality in women and accounts for an unbearable cost of

medical care in middle-aged and older women in the United States today. Between the years 1979-1981 Louisiana

ranked seventh in the average annual coronary heart disease (CHD) death rate among white women and sixth

among black women ages 35 to 74 years. Although the prevalence of early CHD is greater in men, the amount 

of CHD in women after the age of 65 increases significantly; overall, women manifest symptoms of cardiovascular

disease on the average 10 years later than men. The high morbidity and mortality after menopause, however, indicate the importance of studying heart disease in women. Diabetes mellitus is particularly severe in women and 

promotes CHD at an early age. It is also known that cigarette smoking and inactive lifestyles, high fat and high

sodium diets and the marked prevalence of obesity, as well as hypertension and dyslipidemia, contribute to 

severe coronary artery disease in relatively young women.

Studies in the Bogalusa Heart Study, a long-term epidemiologic study on children, adolescents, and young

adults, show risk factors can be identified early in life and the major etiologies of heart disease, atherosclerosis,

hypertension, and adult onset diabetes all begin in childhood. Morbidity in the young adults ages 19 to 32 years

shows that some 10 percent of white females and 22 percent of black females have a BMI greater than 32.3kg/m2,

representing morbid obesity. Of black females, 15 percent already demonstrate hypertension. Further, risk factors

tend to cluster with obesity, increased insulin resistance, hypertension and dyslipidemia. Of particular interest the

clustering of cardiovascular risk factors in young adults, Syndrome X, results in a strong relationship with coronary

atherosclerotic lesions found at autopsy. This clustering is associated with an acceleration of the coronary atherosclerotic lesions. On an average atherosclerotic involvement of coronary vessels tends to be less in young women,

but the severity of lesions can be quite extensive in some individuals, predictive of CHD at a relatively young age.

Poor lifestyles and behavior in youths include cigarette smoking, sedentary activity, and dietary intake. Some 

30 percent of high school students are reporting consistent use of tobacco and alcohol, more in white girls. With

regard to diet, some 80 percent are exceeding the American Heart Association recommendations for total fat and 

saturated fat intake. Decreased physical activity has enhanced a secular trend of increased obesity.

The study of cardiovascular risk factors and lifestyles in children and young adults has serious implications 

for the development of adult CHD, cancer, and osteoporosis. The studies emphasize the need, not only to study

females as adults, but to continue investigations of the early onset of chronic diseases as they begin in childhood.

Such observations can help guide more rational methods of prevention.

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President, Director

James E. Dill, M.D., F.A.C.P. Endoscopic Ultrasound of Virginia

Gallbladder disease and Irritable Bowel Syndrome (IBS) are both common conditions which affect women 

more commonly than men. This presentation will discuss the relationship between these two conditions and 

present a hypothesis for a possible etiologic link between them; especially for the subgroup of patients who 

have histories of abuse or trauma.

A new technique for detecting difficult-to-diagnose gallbladder disease will be discussed. This procedure

involves the groundbreaking technology of Endoscopic Ultrasound which allows viewing of the gallbladder 

and its contents with accuracy not previously possible. A positive result with Endoscopic Ultrasound is highly 

predictive of a good long-term outcome following removal of the gallbladder. Also discussed will be a type of 

gallbladder disease with an overwhelmingly female predominance.

Finally new research on IBS and its relationship to sexual abuse, plus threat of such abuse, will be considered

as well as a collaborative, office-based treatment model. Our results indicate that threat of abuse has a powerful

effect on IBS symptoms. Patients with histories of sexual abuse, combined with threat, will benefit from a unique

treatment approach and environment. Our collaborative treatment model involving the physician, nurse, and counselor utilizes the findings from our research on IBS, abuse, and threat in a practical and compassionate fashion 

and has been tested in both specialty and primary care settings.

Carolyn Evans, M.S.W. Grace House of New Orleans, Inc.

The unique needs of women in substance abuse treatment are not addressed in most traditional substance

abuse treatment programs which are based on male norms. Often such treatment programs are not only ineffective

for women but can actually result in victimization. A holistic treatment model which addresses the physical, emotional, spiritual and sociological needs of women is indicated for safe and effective treatment for female substance

abusers. Negative factors for women in currently used treatment modalities are explored along with a model 

program for gender-specific substance abuse treatment.

Indications for future research needs in gender-specific substance abuse treatment for women are explored.
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Wonda L. Fontenot, Ph.D. Wannamuse Research Institute

This testimony is concerned with the need and relevance of applied research in relation to behavioral health

issues of rural women, especially rural African-American women. An equally important concern is how these

behavioral issues impact access and quality care for women, as well as the adoption of preventive health care 

measures. In the testimony I will call attention to health concerns affecting the health status of women based 

on cultural factors, socioeconomic conditions, and issues of race and gender.

Cultural beliefs and practices associated with causes and treatment of illness, and other lifestyle behaviors, 

are important determinants of health status, and in the prevention of morbidity and mortality. The lack of cultural

sensitivity on the part of health care providers toward the rural recipient, remains an issue in rural communities, 

and continues to threaten the cost of effective health care, and contributes to a higher risk of poor health 

among women.

Issues of gender in rural society is also relevant, as often times medical diagnosis and treatment for women 

is based on the status of women in society. Thus, more research is needed to improve the quality of health care 

for women, and to fully understand the impact these variables have on the well being of women who are rural,

poor, and/or African American.

Assistant Professor of Clinical Pharmacy

Julie E. Goslee, Pharm.D. Xavier University of Louisiana

Gender Differences in Prescribing Postmenopausal Hormonal Replacement Therapy

A growing number of women are living longer (up to one-third of their lives) after their reproductive years,

and physicians and pharmacists find themselves increasingly needing to intelligently discuss the issue of hormone

replacement therapy (HRT). Concerns such as “How will HRT help me?” “How will it hurt me?” “Is it right for me?”

and “How do I take it?” are often asked of both the physician and the pharmacist.

Our understanding of the benefits of HRT has expanded greatly in the last 5 years. Effects of HRT can be 

measured in the potential for lives saved or lost, but it also may improve many harder to measure quality-of-life

factors. Postmenopausal hormone replacement therapy has been shown to be cost-effective in decreasing morbidity and overall mortality in users, especially with long-term use. 

So then, why are only 3 to 15 percent of eligible women receiving HRT?

This may be partially due to uncertainty regarding the risks versus the benefits of HRT. Strong scientific 

evidence that HRT may decrease the incidence of hot flashes, urogenital atrophy, incontinence, osteoporosis, and 

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cardiovascular disease is tempered by uncertainty regarding its effects on the risks of stroke and breast cancer.

While the infrequent usage of HRT may be related to these risks, other factors may also contribute to its pattern 

of use. Research of physician behavior indicates that practice patterns differ between female and male physicians 

suggesting that physician-specific factors may influence the decision to perform particular tests or to prescribe 

certain medications. Patients seen by female physicians are more that five times as likely to begin ERT than those

seen by male physicians according to Seto, et al. (J Gen Intern Med 1996;11:197-203). These gender differences 

are also seen with cancer screening rates; female physicians perform more cancer screening tests for female 

patients than do male physicians. 

After reading this study (and to my knowledge, Seto, et al. were the first to report on the impact of physician

gender on the prescription of ERT in actual clinical practice), I wondered if these same differences could be seen 

in the pharmacy profession. Very often, the pharmacist is consulted by the patient for answers to questions about

their medications, and could there be differences in the knowledge and attitudes about ERT/HRT between male 

and female pharmacists?

Further research is required to determine if these differences reflect differences between male and female 

physicians and pharmacists in knowledge or attitude about ERT/HRT, or gender-specific differences in how 

physicians and pharmacists discuss ERT/HRT with their patients.

Assistant Secretary, Office of Alcohol and Drug Abuse

Alton E. Hadley Louisiana Department of Health and Hospitals

The following are a list of recognizable health-related issues reported among our State Operated 

Women’s facilities:

• Gastrointestinal problems • Insomnia

• Respiratory problems • Sexually transmitted diseases

• Dermatological problems • Seizure disorders

• Eye infections • High blood pressure

• Dental problems • Controlled diabetes

• Urinary tract infections
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Several medical concerns are cited as barriers to women seeking treatment, including very high risk pregnancy,

uncontrolled seizure disorders, and any problem that absolutely requires medication with abuse potential such as

benodiazepines, sedative-hypnotics, narcotic and opioid analgesics, and some skeletal muscle relaxants (i.e., SOMA).

The single most common medical problem that interferes with clients in treatment (other than antibiotics) 

is the need for dental care. A history of neglectful dental hygiene is common in substance abusing clients. Once in

treatment, toothaches and dental abscesses can be severe and some facilities do not have dental services available.

Clients usually have no resources to access private dental care. 

In summary, we advocate the following recommendations:

A. Education and outreach services need to be available to more women and their families in order 

to provide information on risks and the preventive steps that should be taken to avoid or reduce 

addiction to alcohol and/or drugs.

B. Medical professionals need to be adequately trained in the alcohol and drug abuse field, so that 

they can recognize and better counsel women on prevention and treatment needs.

C. There is a greater need for expanded research projects with a focus on the needs of women.

Council Woman, 29th District (Nashville, Tennessee)

Saletta A. Holloway Meharry Medical College

Health care is influenced by several factors, including the medical needs of patients, the environment for

research and major socioeconomic trends. Other important parameters are the societal expectations for health 

care delivery. Besides being familiar with the health care environment, I am a Council woman for the 29th District. 

In that capacity, I come in contact with people in my community who have different expectations about health 

care delivery and biomedical research. I can summarize those concerns as follows:

• Health literacy. Consumers need to understand the enormous amount of information about technological

advances and health care delivery systems.

• The concept of disease. Public perception of disease is changing. People now understand that diseases can 

be caused and aggravated by many factors, including biological as well as socioeconomic factors. Also, 

there is a shift in focus from acute to chronic disorders.

• The need for health promotion and disease prevention.

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• Management of disease. The public understand the need for a comprehensive delivery of health care, 

which takes into account their specific disease and individual needs.

• Health care cost. Emphasis has been given to the cost of hospitalizations, physician payments, and diagnostic tests, while ignoring the high cost derived from lack of prevention, lack of access to health care, 

and lack of knowledge about health. Preventive medicine should be introduced as one of the elements 

which contribute to contain and rationalize health care cost.

• Research focus. Few people benefit from technological breakthroughs, while a high number of our citizens 

lack access to elemental health care. The public is recognizing that the health of our population in general 

is as important as the health of individuals. While we recognize the value of genetic engineering, we also 

clamor for a broadening the base of research areas to find answers on the impact that socioeconomic have 

on the health of our citizens.

• Inclusion of women and minorities in research. The public celebrates legislation mandating the inclusion of 

women and minorities in biomedical research. While the legislative mandate is clear, poor women and 

minorities are not participating in biomedical research.

I respectfully make the following suggestions to the National Institutes of Health:

• Develop policies for health promotion and disease prevention.

• Promote research which has an emphasis on population-care management and focus on specific groups 

such as women, minorities, and pediatric and elderly populations.

• Design strategies and policies to promote the development of women scientists.

• Promote research which looks at disease-management approaches based on clinical as well as socioeconomic factors.

• Promote research which finds approaches to manage diseases through early intervention and prevention 

of exacerbations. Technologies should be used to educate patients, physicians, and health care organizations,

rationalize the use of medications and modify the environment.

• Promote research on how to obtain and manipulate health data from specific populations. Develop 

the resources and the technology to pull data together and apply it.

• Promote research that looks at quality of care and quality of life throughout the life span.

• Sponsor programs to assist research subjects who can not afford to participate in research trials.
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• Make the necessary budgetary allocations to increase the visibility and productivity of women’s programs 

at the National Institutes of Health, including those efforts related to the inclusion and retention of women 

in biomedical research. Special attention should be given to the Office of Research on Women’s Health.

• Promote large clinical trials which look at unknown causes of disease, and have clear clinical endpoints, 

such as the Women’s Health Initiative.

• Find innovative and effective ways to facilitate the involvement of the public in defining the research 

agenda for this nation.

Marlene Keeling, B.S.B.A. Founding Director, CANDO

Research on Women’s Health for the 21st Century Needs To Include Chemicals Implanted in the Body

When breast implants are removed, they are labeled biohazardous or poisonous. The FDA has never approved 

a single breast implant. Women have been experimented on for the last thirty years. How many deaths does it take

before this public health hazard is removed from the market? Now is the time to stop the experiment and do the

research before one more woman’s health and that of her children born after implantation is destroyed by the toxic

effects of silicone and silica. Secret Scandinavian research in the 1970s revealed that 2,6-cis-D which is very similar

to D4 found in breast implants had estrogen-like activity, caused atrophy of male sexual organs, caused abnormal

motility and eventual sperm death, caused stimulation of endometrial growth, caused many other harmful effects,

and definitely passed the placental barrier in pregnant mice. We know more about the fetal effects of Tylenol than

we know about the effects of silicone/silica. Every child deserves to be born free of toxic chemicals. Is it possible

that in this advanced technological age, we are poisoning ourselves and our future generations?

I recently coordinated a data gathering of 100 breast implanted women from different support groups around

the country which revealed the following: 68 percent had been diagnosed after implantation with peripheral neuropathy, 36 percent demyelinating neuropathy, 70 percent atypical neurological disease, 42 percent organic brain

syndrome (loss of cognitive function), 52 percent lupus or lupus like, 87 percent fibromyalgia, 78 percent atypical

connective tissue disease, 39 percent mixed connective tissue disease, 12 percent scleroderma, 55 percent esophageal reflux, 63 percent gastrointestinal dismotility, 95 percent chronic fatigue, and 47 percent Sjögren’s syndrome.

No one seems to be focusing on the neurological part of the toxic effects of silicone/silica. Women with implants

are being diagnosed with reduced blood flow to the brain, brain lesions and tumors, and loss of cognitive function

(it appears to be an adult form of attention deficit disorder). Is it possible that silicone/silica is a lipid soluble neurotoxin? Many former hard working productive women with implants are now disabled, without insurance, unable

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to take care of themselves or their families. The Blue Cross/Blue Shield underwriting guidelines now state that 

the response to a woman with breast implants is to decline her coverage. This health care crisis grows daily, 

while the manufacturers would try to blame it on anything but the implants.

Over 1,300 peer-reviewed research articles indicate the harmful effects of silicone/silica in the body. Dr. David

Kessler’s article in the Annals of Internal Medicine states: “. . . 71 percent of the women . . . had either frank rupture

or severe silicone bleed at explantation” and “. . . because most studies have focused on well-defined connective tissue

disease, they cannot rule out the possibility of an elevated risk for one or more distinct, atypical connective tissue

disease-like syndromes that do not meet the standardized diagnostic criteria used in most studies.”

Clinical studies are now needed to verify what implanted women have known for some time — something 

has gone disastrously wrong. It is time to spend our research dollars finding possible preventative causes of 

disease and remove harmful non-life-saving devices from the market.

Professor and Chair, Tulane University School of 

Judith H. LaRosa, Ph.D., R.N., F.A.A.N. Public Health and Tropical Medicine

The Cause for Enhanced Behavioral Research

As a result of the tremendous focus on biomedical research and dissemination of the findings, Americans 

and their health care providers have access to vast quantities of health information. These data enable us to 

prevent, identify, and control disease. Many live longer and better. However, a substantial number of individuals 

do not act, or act haphazardly, on such life-saving information.

Of particular interest is why women, who compared to men are by far the more dedicated seekers of health

care, are so resistant to life-preserving change? Why do young women persist in smoking and engage in unprotected

sex? Why do older women resist mammograms and Pap smears? Why are younger female physicians more likely to

prescribe preventive services than older male and female physicians? Is the health professional community sending

the wrong messages? Are the messages too much the “one-size-fits all” approach? Does the media with its “latest

medical news report” confuse?

We need to examine the differences in the sexes in response to health information and action. We need to

determine how to reduce barriers and enable women to act in their own best interests. Learning is not a one-way

street from health care professional to patient. Learning is a multifaceted collaboration among women and their

health care professionals to protect and enhance the health of the individual. This is especially important now 

when health care is changing and professional time with patients is being reduced. Behavior change requires 

understanding, time, and commitment by many forces from the individual and her physician to the media.
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I urge the following action for NIH and all research institutions dedicated to health promotion and disease:

1. Recognize and accept that differences exist among individuals and between women and men. Recognize 

that individuals have different ways of learning and adopting behavior change.

2. Allot sufficient funds to support behavioral research and make it a priority across the myriad of diseases, 

disorders, and conditions that affect women — and men. Without such research we cannot successfully 

apply and have individuals adopt the health preserving findings.

3. Integrate behavioral research into as many clinical studies as possible.

Indeed, a great deal of the information is often already there. It simply needs to be identified and utilized.

This is not a plea to rob basic or applied sciences of their critical role or funds in biomedical research. This 

is an urgent request to acknowledge and stimulate the critical role behavioral research has in biomedical research.

Behavioral research is important for it enables us to use effectively the continually emerging research knowledge —

as individuals and as a nation.

Marva L. Lewis, Ph.D. Assistant Professor, Tulane University School of Social Work

There is little research that focuses on the role of culture and ethnicity as normative processes that permeate

the mental health and well being of the lives of women and girls. For example, there are some cultural practices

and strong ethnic identity may be sources of strength as well as sources of vulnerability for women and girls in

view of the current public health crisis of interpersonal violence. We do not understand the mental health needs 

of women and girls who are the victims, mothers, sisters, girlfriends, and daughters of the epidemic of homicide 

that have defined urban settings in the nineties. What will psychological legacy be of the next generation of 

children who will be parented and socialized by mothers with experiences of unresolved grief and loss?

In the current research I am conducting with funding provided by the National Institute of Mental Health, 

I am investigating how the task of hair combing may serve as a naturalistic paradigm for research to understand 

the dynamics of African-American mother-daughter relationships. The hair combing task offers an opportunity to

compare and contrast the quality of interactions that occur in this observational context with the interactions that

occur in traditional contexts of assessment such as free play and teaching tasks. Developmental theories of attachment, self conception formation, and racial socialization provide a conceptual framework for understanding the

significance of Hair Combing Interactions (HCI) and basis for the design of the study. Intense emotions are associated with hair. The critical nature of skin to skin human touch has long been established and more recently, the

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importance of parent to child nurturing touch to enhance the development of secure attachment relationships. During HCI mothers must repeatedly touch, pat and smooth the hair of the child. Consequently, the functional aspects 

of HCI offer an opportunity for attachment as well as intimacy. The interactions that occur between mothers and

their daughters during the task of hair combing may contribute in important ways to the infant girls developing

sense of self and reflect stable attributes of the relationship and the mother’s general parenting style. HCI as a

method of assessment also offers a potential window for understanding the sociocultural domains of AfricanAmerican girls emerging sense of gender and racial self concept formation. In data from pilot studies I have 

completed with diverse samples of African-American women and girls in three different cities, I found it was 

possible to rate a variety of discrete maternal and child behaviors from videotapes of the interaction.

This study is a descriptive and exploratory study of a low-risk, non-clinical sample of African-American mothers,

ages 20 and older with daughters ages 20 to 36 months. The specific research questions this study addresses are:

Does African-American mother-daughter interaction look the same in three observational contexts (free play, teaching, and hair combing)? Is the mother’s ethnicity the best predictor of specific behaviors in hair combing context?

The relationship variables of interest are the mother’s emotional availability; the child’s affect and level of compliance with the mother and the overall connectedness and exchange of affect between the mother and the child. 

Each of these behaviors will be analyzed from videotaped interactions in each of the three contexts.

There is a conceptual gap in the research about specifics of the role of culture in the mental health of AfricanAmerican women and girls. The American Psychological Association and ethical standards committee of the Council

of Social Work Education have both recommended that race and ethnicity be considered in the construction and

methodology of research studies. It is time to move beyond simple inclusion of descriptions of the race and ethnicity of study participants. Cultural heritage and traditions must be the beginning point for conceptualization, design

and interpretation of research conducted on women and girls. I have provided a brief example of my research

where a cultural conceptualization of the mother-child relationship led to the selection of hair combing task 

as a valid method of research.

In conclusion, I recommend the following actions:

1. That funding priority be given to the development of an annotated bibliography that brings together 

the existing research that examines culture and mental health of women and girls.

2. Researchers, clinicians, and students and educators be provided with continuing education in the 

form of workshops that help them understand the differences between the concept of culture, race, 

and ethnicity. In our current context of our collective weariness over the battle for affirmative action, 

our reactivity and fear of discussions of racism and ethnic relations the topic of culture becomes subsumed and typically lost. If culture is going to be substantively explored that there must first be a 

clear understanding of the construct.
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3. There is need for collaboration and interdisciplinary focus in order to substantively address the issue of 

the role of culture as a source of protection and vulnerability in the lives of African-American women.

4. Basic research on African-American cultural traditions and practices related to women’s roles need to 

be made a priority with funding priorities given to studies that describe the meaning of culture in order 

to build theory and hypothesis about African-American culture.

Chief, Women’s Health Research Program

Jennifer C. Lovejoy, Ph.D. Pennington Biomedical Research Center

The mission of the Pennington Biomedical Research Center (PBRC) at Louisiana State University is promotion

of healthier lives through research in nutrition and preventive medicine. As part of this mission, PBRC is committed

to research in women’s health issues, many of which have a nutritional component.

At the Public Hearing on Issues in Women’s Health Research, women’s health issues will be discussed broadly.

PBRC brings a unique perspective to this topic in the special area of nutrition and preventive medicine and we will

use this perspective to highlight aspects of the broad field of women’s health research. We have chosen “Nutrition

and Women’s Health Across the Lifecycle” as the theme for PBRC’s statement because nutritional issues such as obesity and eating disorders have major implications for the nation’s health and there are important gender differences

in the prevalence of these health problems. Furthermore, as in many other areas of clinical research, women have

been under-studied with regard to the relationships between nutrition and chronic disease and there is much to 

be learned about the physiological responses of women to nutritional changes.

Because of the influence of reproductive hormones as well as a number of psychosocial factors, there are several

periods during a woman’s life when she may be at greater risk for developing a nutrition-related disorder. These

times include adolescence, when eating disorders typically appear, and pregnancy and menopause, when excess

weight gain may be a problem. Furthermore, unlike men, women experience fluctuating hormone levels across a

monthly cycle. These changing levels of hormones throughout the menstrual cycle in reproductive age women have

been associated with altered food preferences and eating behavior which, over time, may contribute to nutritionrelated problems such as obesity in certain women. The unique nutrition-related health risks women may experience at different points in their lives include:

1. Childhood and adolescence. Childhood obesity, eating disorders (anorexia and bulimia), and teen 

pregnancy are major public health problems that put adolescent girls at risk.

2. Pregnancy and lactation. Pregnancy and lactation impose a significant physiological and nutritional stress 

on women, while over-nutrition and excess weight gain during pregnancy can lead to permanent obesity.

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3. Mid-life and menopause. Menopause may be associated with an increase in body fat and a shift in 

location of body fat from the periphery to the abdomen and may explain in part the increase risk 

for heart disease that women experience after menopause.

4. Aging. Elderly women are at risk for a number of nutrient deficiencies which may impact their health 

status ranging from inadequate intakes of antioxidants to calcium.

We will describe several of the ongoing research projects at PBRC exemplary of nutritional issues in women’s

health research which cross the spectrum from the laboratory to the clinic to the field.

Associate Professor of Biostatistics 

Department of Biostatistics and Epidemiology

Frances J. Mather, Ph.D. Tulane University, School of Public Health and Tropical Medicine

The Importance of Research To Identify Factors Associated with the Reduction of Preterm Births

Preterm birth (less than 37 weeks gestation) is the major pregnancy related problem in the United States. 

It accounts for nearly 75 percent of the infant deaths in the first month of life and as much as 50 percent of longterm neurological damage in children. It is the major contributor to low birthweight. Annual direct costs 

attributed to preterm births in the U.S. have been estimated to be at least 4 billion dollars.

Preterm birth among black women occurs in about 12 percent of live births, approximately twice that of white,

Hispanic and Asian women. Low birthweight is associated with an increased risk of subsequent hypertension and

death due to cardiovascular disease. Weight at birth and social conditions of childhood are found to affect reproductive capacity. Neurological conditions include cerebral palsy and attention deficit disorders. Other conditions

include retinopathy of prematurity, SIDS, bronchopulmonary dysplasia, and other chronic pulmonary conditions.

Recent declines in infant mortality, largely attributed to the use of surfactant and other neonatal interventions, 

have resulted in increasing survival of extremely preterm deliveries at risk to these sequelae.

Little or no evidence is available that preterm prevention programs, social support for pregnant women, 

early prenatal care, education to increase awareness of the signs of preterm labor and the use of tocolytic therapy 

to suppress uterine contractions have been successful.

Promising new developments to explain preterm birth and low birthweight include the assessment of the role

of infections in preterm births, especially bacterial vaginosis. Treatment with metronidazole and erythromycin has

reduced rates of premature delivery in women with bacterial vaginosis and at increased risk for preterm delivery.
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The burden of preterm birth falls heavily on black women, many of whom are poor. The cost of preterm birth

is high and the sequelae long lasting and among the very-low-birthweight, severe and irreversible. Recent innovations in neonatal intensive care make it possible for greater proportions of tiny infants to survive, but not without

the sequelae associated with this condition. About 40,000 to 50,000 of these very-low-birthweight infants per year 

in the U.S. will, in succeeding years, require additional funds to address the physical, mental and educational handicaps subsequent to preterm birth. Cuts in Medicaid and SSI will certainly impact the financing of needs for this

growing population. A number of promising studies support the hypothesis that infections may play an important

role in the incidence of preterm birth. I urge that research in the identification of preventive factors associated 

with preterm birth be made a priority.

Danita M. Muse, M.S.W. Women With A Vision, Inc.

African-American women, often members of the poorest communities in America, have the highest death 

rates in America from cancer. In a culture where it is believed that if you do not feel sick, then you are not sick, 

it is no surprise that we are dying more often from lung, breast, and cervical cancer. The prevention and treatment

messages are not getting through. Treatment agencies are amazed at the condition of that eventually appear for 

services in emergency rooms.

With HIV/AIDS/STDs, it was certain that the poorest communities would be hardest hit, and more devastatingly, by a disease with no clear outward signs. Treatment administered on the tail of research will always cost

more than those of my community can afford. Prevention practitioners must constantly play catch up regarding 

the disease’s “trends,” with an only recent arrival of culturally appropriate messages and messengers. This is just 

the tip of the iceberg.

African-American women are living in communities where violence is normal. The physical effect of that 

violence, in death and abuse, will only be matched by the damage done to our faith and hope! My community 

is being left with an even larger terminal illness as result of violence.

What has research done, beside telling us what was wrong? Do researchers come to us and ask us? Do

researchers look like us? Research should be done to show a connection among all of the illnesses affecting 

our communities’ members. These illnesses collectively have a unified effect upon my community!

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Medical Director for Women’s Health

Marcy Ouellette, M.D., M.P.H., T.M. Louisiana Office of Public Health

The Louisiana Office of Public Health, Division of Health Services, houses the Maternal Child Health and 

Family Planning Programs, both of which provide preventive services to women and female adolescents of reproductive age and their children. During the fiscal year, 1995-96, approximately 200,000 women and 148,117 

children used our medical and nursing services. These women are mainly impoverished, underserved, and 

disenfranchised. Despite intensive efforts, and assistance at the federal, state, and local levels, improving the 

health status of the women who entrust themselves to our services remains difficult. Why? 

This is a question many of us who are committed to public health services constantly struggle with. Is it 

poverty and its enormous destructive consequences, institutionalized racism and sexism, social inequalities, 

or are there other more subtle differences among women who utilize public health services? Although research

regarding women’s health is improving, there continues to be a lag in reliable information regarding women of

color, adolescents, and the disparities that exist between women who utilize public services versus private, women 

of color and whites, and among women of color themselves. Epidemiological, scientifically tested rates and 

prevalence among these groups is difficult to document. Yet, without them, funding to address these issues 

is not forthcoming.

Despite enormous social, economic, racial barriers, and fragmented health services, many women who 

utilize our public health services have health strengths and coping strategies that enable them to live healthily 

and productively, and raise healthy children who are safe and constructive. We seldom look at this. 

Research historically looks at illness rather than health. To understand how women prosper and protect 

their and their children’s health and well being, despite enormous odds, would in fact enable us to design 

interventions based on individual and cultural strengths, which may ultimately have a greater impact.

With the expectation that research conducted on women will involve women in the planning and design, 

implementation, evaluation, and interpretation of results of research studies, and who are from a multicultural 

and socioeconomic diverse background:

1. How the perception of being a public health recipient (particularly from a young age onward) where

choice of provider, appointment days and times are usually not self selected, and services are generally 

monetarily free, affects women’s self identity and self reliance, particularly one’s ability to make independent reproductive and other healthy life choices. 

2. How gender identity and responsibility are affected and contributed to by reproductive health clinics 

that primarily focus on the female.
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3. How well informed are women regarding informed consent as it pertains to research involving reproductive health, contraception, and STD/HIV. How comfortable women are in actually refusing to be part of 

a study. Specifically, how women who cannot say no to a study involving their reproductive health can

effectively say no to other issues and actions involving their reproductive health.

4. Infant mortality and low birthweight disparities between blacks and whites.

5. Effects of the media on healthy gender identification and sound health practices on female adolescents 

and adult women.

6. Continued multicultural, sound, contraceptive research and development because 60 percent of all 

pregnancies continue to be unintended.

These issues mainly focus on reproductive and sexual health care needs of women, primarily because these are

the issues our programs address. We continue to need research addressing cardiovascular disorders, endocrine disorders, osteoporosis, and mental health and illness, but, these health concerns are not controversial and do not

come under the same political scrutiny as do reproductive and sexual health issues. To maintain and improve the 

status of women, we must ensure that these issues be addressed.

Director, The Center for Sexual Health

Eileen M. Palace, Ph.D. Tulane University Medical Center, School of Medicine

Research and scientific knowledge on the sexual health of women has lagged far behind that of men. Masters

and Johnson (1970) estimate that at some point during a relationship, one of every two couples experiences sexual

difficulties. For women, the prevalence of orgasm disorders is estimated at 30 percent and the prevalence of sexual

desire disorders estimated at 20 percent (DSM-III-R,1987). This means that, conservatively, orgasm disorders affect

over 23.5 million women and desire disorders affect over 15 million women in this country. The inclusion of other

types of sexual dysfunction affecting women (e.g., sexual arousal disorders, sexual pain disorders, vaginismus), and

associated psychological disorders (e.g., depression, anxiety) would provide estimates many times greater. Despite

the pervasiveness of sexual disorders in women, very little is known about the basic mechanisms that mediate 

sexual arousal and response in women, only a handful of researchers in the country conduct research on the 

sexual psychophysiology of women, and as a result, research on women’s sexual functioning and knowledge 

of women’s sexual health is lacking.

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There is growing awareness of the absence of medical and clinical research on women’s sexuality and the detrimental effects of our gender-biased knowledge. Research funding is needed to foster new programs of research to

(a) define the construct of sexual arousal, (b) determine valid and reliable assessment instruments, (c) identify an

etiological model of sexual dysfunction, and (d) develop effective, empirically based treatment methods for the alleviation of sexual dysfunction in women. This testimony presents recent advances in knowledge on women’s sexual

functioning and the potential for new research programs to revolutionize current knowledge on women’s psychological and physical health. It presents current findings that identify mechanisms in the etiology, treatment, and

prevention of sexual health-related problems for women, and provides implications for new health psychology and

behavioral medicine approaches for the prevention and alleviation of psychological and medical disorders. This 

testimony presents suggestions for new research programs, that if fostered, may provide new behavioral medicine

approaches to treatment, where instead of surgery or pharmaceutical techniques, changes in behavior and cognition are used to change physical problems. United research efforts are needed to instigate programs to facilitate

understanding women’s sexual health requirements, to pursue new approaches to improve the quality of health

care, and ultimately, to promote mental and physical sexual health for women.

Committee on Women’s Affairs

Jayashree Rao, M.D. Louisiana State University

Career Issues for Women Scientists and How To Overcome Them

Barriers:

1. Women are biologically different and that has an impact on how they view science, and their 

contribution to the advancement of science. 

2. Socialization of women during childhood, adolescence, and young adulthood is different, and 

that has an impact on the way they perceive a career in science.

3. Women’s roles, as governed by the societal norms, make it extremely difficult to participate 

and benefit from traditional programs that are now in place to foster a career in science.

4. The traditional type of mentoring process does not address the gender differences in fostering 

the careers of women scientists.

5. The life cycle of women’s creativity and productivity are different and there are virtually no 

programs that address this difference.
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Adequate numbers of women are choosing careers in science. Yet, their progress and creativity 

do not meet their full potential.

Solutions should be aimed at:

• Mentoring that is mindful of the gender differences.

• Time course for career advancement that recognizes the women’s needs to balance multiple roles.

• Newer programs that encourage and foster senior women’s entry and progress in scientific careers.

Co-coordinator

Meghan-Morgan Shannon, M.S. Medical Professionals/Persons with CFIDS/CFE/ME

Anecdotal evidence suggests that the preponderance of those affected by CFIDS/CFS/ME and related immune

disorders are health care professionals. Clearly, considerably more epidemiological evidence is required if we are to

understand the incidence and prevalence of this emerging entity in the population. Is it largely a “White woman’s

disease,” or does it affect, but remain largely undetected among, other racial and ethnic groups? Which men are

affected and why? Is it more common among medical workers (nurses, respiratory therapists, M.D.s, lab techs)

than other professions? Is it because the medical profession consists mostly of women who are on the front line

with greater exposure to environmental toxins, viruses, bacterias, or mycoplasmas, combinations, or other factors?

Emerging evidence indicates that CFIDS/CFS/ME may trigger a variety of autoimmune diseases — diseases

which tend to be more prevalent among women than men. Thus, steroidal sex hormones are likely to play an

important and integral role in the development of CFIDS/CFS/ME and other immune disorders. What is clear 

is that epidemiological data are required to guide hypothesis generation and hypothesis testing. In an area of

shrinking research resources, we must know where to focus research action.

Evidence gathered to date has already shown that early detection and intervention can mitigate the course 

of the disease, e.g., the earlier the intervention, the more complete and rapid the recovery (if there is to be any

recovery). Yet we need a clearer and more comprehensive understanding of the genesis and course of CFIDS and

related disorders if we are to avert it entirely, or to intervene at the earliest stages when recovery is more easily

achieved. Furthermore, data gathered from CFIDS/CFS/ME investigations will undoubtedly lead to discoveries 

in related diseases and disorders.

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Amanda Sherman President, DES Action USA

DES Action USA is a national nonprofit organization representing an estimated 10 million mothers, 

daughters and sons exposed to the drug DES (diethylstilbestrol).

The purpose of DES Action USA is to provide education and support to those exposed to DES, to increase

public awareness about DES so that individuals can discover if they are exposed, and to educate medical professionals so they can provide knowledgeable services to DES exposed people. We also seek to keep public attention 

on the story of DES as a reminder of the need for vigilance in regard to health care practices.

DES Action USA and the DES Cancer Network are the only consumer groups to which DES-exposed 

Americans can turn for support, information, and education.

• Facts about DES, a synthetic estrogen, and numbers exposed in U.S.

• Health effects for DES daughters resulting from in utero exposure to DES.

• Previous research efforts led by Office of Research on Women’s Health, NIH.

• Present and pressing research questions faced by DES daughters.

Institute of Women and Ethnic Studies

Denese O. Shervington, M.D., M.P.H. Women of Color Reproductive Health Forum

The Institute of Women and Ethnic Studies (IWES) is a nonprofit 501 (C)(3) organization dedicated to

improving the physical, mental, and spiritual health and quality of life for women, adolescents, and people of 

color, in particular the poor. The overall goal is to develop culturally proficient, multidisciplinary and holistic

health intervention programs, activities, and research models. The Institute of Women and Ethnic Studies is 

recommending a new approach, a restructuring of biomedical research that would include the full representation of ethnic groups in the strategic planning, discovery, development, testing and evaluation, and distribution of new reproductive health drugs and devices.

1. The development of safe and effective contraceptives must be encouraged and supported:

– Contraception must not be used as a vehicle for coercive social policy.

– Contraception must not be separated from disease protection (STD/HIV) but instead be 

integrated into a holistic approach to women’s health.
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– Contraception research agenda should be expanded to include more contraceptive 

options for men.

2. New FDA regulations for the study and evaluation of gender and racial differences in the 

clinical evaluation of drugs must be encouraged and supported:

– Increase the participation of subgroups (by gender, race, age) in clinical trials, especially 

when medically important.

– Increase the analysis of the pharmacodynamics and pharmacokinetics among subgroups.

– Encourage clinicians of color to participate in clinical trials.

3. FDA must monitor post-marketing surveillance of drug safety and efficacy.

4. A system must be developed for reporting, monitoring, and responding to consumer and/or 

provider reports of side effects.

5. A system must be established for safeguarding against drug misuse (by misleading marketing 

to consumers of inappropriate prescribing by providers).

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY
Leah L. Albers, C.N.M., Dr.P.H.

University of New Mexico College of Nursing

Kathleen Blake, M.D.

New Mexico Heart Institute

Jeanne Carritt, M.A., M.Ed.

Lois Grey Long, R.N., M.S.N.

Selves

Jean Charles-Azure, M.P.H., R.D.

Nutrition and Dietetics Training Program

Col. Laurie Davis, Ph.D.

U.S. Army Nurse Corps

Jane L. Delgado, Ph.D.

National Coalition of Hispanic Health and Human 

Services Organizations (COSSMHO)

Sally Esposito, M.S.

The City of New Haven

Cordelia Gilkyson, C.M.T.

The Endometriosis Association

Linda A. Gonzales, M.A.

New Mexico Disability and Health Program

Janet Greenwald

Citizens for Alternatives to Radioactive Dumping

Barry Halber, M.P.A.

Self

Albert C. Hergenroeder, M.D.

Baylor College of Medicine

Penelope Kegel-Flom, Ph.D.

Association for Women in Science

Gwendolyn Puryear Keita, Ph.D.

American Psychological Association

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Daniel Kerlinsky, M.D.

Self

Wilhelmina A. Leigh, Ph.D.

Joint Center for Political and Economic Studies

Susan Lewis

Self/Independent Living Center 

Albuquerque and Roswell

Rosemary Locke

Y-ME National Breast Cancer Organization

Ann Martin-McAllen, M.S., Ph.D. (c)

Self

Ann McCampbell, M.D.

Multiple Chemical Sensitivities Task Force 

of New Mexico

Martha A. Medrano, M.D., M.P.H.

Medical Hispanic Center of Excellence

Holly Neckerman, Ph.D.

Navajo Division of Health

Electra D. Paskett, Ph.D.

Women’s Health Center of Excellence of 

Bowman Gray School of Medicine

Sally Piscotty

The National Association of Women’s 

Health Professionals

Charles D. Ponte, Pharm.D. 

Self

Linda Ransom

Self

Joan Y. Reede, M.D., M.P.H., M.S.

Harvard Medical School

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PUBLIC TESTIMONY

SANTA FE, NEW MEXICO 

JULY 21, 1997
356

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Karen C. Renick

DES Action USA

Col. Irene Rich

U.S. Army Medical Research and Materiel Command

Peggy Roberts, M.D.

Self

Gail Robin Seydel

Action for Women’s Health

Cynthia M. Shewan, Ph.D.

The American Physical Therapy Association

Susan M. Shinagawa

Self and Intercultural Cancer Council

Susan Silverton, M.D., Ph.D.

American Association of Dental Schools

Linda C. Skidmore, M.S.

National Research Council/Committee on 

Women in Science and Engineering

Anne Stansell

United Silicone Survivors of the World

Leah Stiemel, M.D.

New Mexico PreNatal Care Network

Cecilia Téllez

Self

Patricia King-Urbanski, R.N., 

M.S.N., C.C.E., L.C.S.

Associates of Women’s Health, 

Obstetric and Neonatal Nurses

Sandra Welner, M.D.

Self

Joanne M. Williams, R.N.C., C.N.P.

Self

Caroline J. Yu, M.P.A.

National Asian Women’s Health Organization

Diana Zuckerman, Ph.D.

National Women’s Health Network/Institute 

for Women’s Policy Research
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Associate Professor, University of New Mexico 

Leah L. Albers, C.N.M., Dr.P.H. College of Nursing

Each year in the United States, some 3.9 million babies are born. The clear majority of these are born to

healthy women, that is, women without medical problems which either precede pregnancy or arise during the

course of pregnancy. For historical reasons, about 99 percent of all babies are delivered in U.S. hospitals. Thus, 

normal childbearing accounts for a large portion of the total U.S. health budget. In fact, “normal pregnancy, 

delivered” is one of the most common discharge diagnoses from U.S. hospitals.

American childbearing women receive more technical procedures during labor, and are more frequently 

delivered by surgical methods than are women in any other developed country in the world. The excess use of 

technology and surgery is problematic for two reasons: (1) it is extremely expensive. These financial resources

could be better directed elsewhere, to benefit all childbearing women and their infants, and (2) it engenders 

excess morbidity, in terms of both unnecessary medical complications and adverse psychological outcomes. 

In the important transition to motherhood, none of these can be considered insignificant.

There are many examples of overtreatment of childbirth in America. One, is the high rate of cesarean delivery in

the United States. Although the C-section rate has declined from its all-time high in 1988 of 24.8 percent, it now

stands at 21 percent, approximately twice that of countries in western Europe. Some 30 percent of women delivered by cesarean are known to have significant postoperative morbidity, breast-feeding failure is higher in these

women as well. Four technical procedures used during labor in the U.S. can be described as excessive: electronic

fetal monitoring, labor augmentation with oxytocin, epidural analgesia, and episiotomy. Electronic fetal monitoring

has risen from 45 percent of all U.S. births in 1980 to 81 percent of all births in 1995. Augmentation of labor with

intravenous oxytocin is becoming mainstream care. Clearly the operational definition of normal labor progress needs

reevaluation when 1 in 6 labors are defined as “too slow.” Epidural analgesia has been termed the “twilight sleep of

the 1990s.” In 1981 it was used for 16 percent of all U.S. births. Since, then, no national estimates are available, but

large institutions report rates of 30 to 60 percent, and higher. Episiotomy remains a common practice; it accompanies 50 percent of vaginal births in the United States. Numerous studies including randomized trials show that 

no short- or long-term benefits accompany routine episiotomy at birth.

Obstetrical care in the United States has a very big problem: we are doing too much of the wrong things 

and not enough of the right things. NIH is encouraged to place the proper treatment of normal pregnancy 

and childbirth (including appropriate technology) on the national research agenda. The following questions 

are examples of those which need to be addressed:

• How can childbearing women be effectively prepared for labor?

• How should labor be managed to increase the proportion of normal deliveries?

• How should labor be managed to reduce postpartum morbidity?
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• How does the style of care during labor relate to long-term health issues: mother-infant interaction, 

breast feeding, etc.?

• How can clinicians be encouraged to reexamine the science base for their practice?

• How can medical educators redefine teaching priorities around normal childbirth?

Kathleen Blake, M.D. New Mexico Heart Institute

I am a cardiologist with the New Mexico Heart Institute and chair of the committee on Women and Heart

Health of the New Mexico and Arizona American Heart Association Affiliate. This committee was established in

1990 by the American Heart Association and the Department of Health of the State of New Mexico to promote

awareness in the professional and lay communities about the problem of heart disease in women. After meeting 

our professional educational objectives first, we have shifted our focus to community programs for prevention 

and early heart disease detection. My comments address the information needs of organizations such as ours 

as we design programs and educational materials for women.

Cardiovascular disease will kill 450,000 American women this year. Most women do not know this. They 

will cite breast cancer as their number one health concern, although this disease takes the lives of just over 

40,000 women in the U.S. per year. Women are, therefore, unlikely to seek out information about heart health 

for themselves. They are less motivated to adopt heart healthy behaviors. They are also, unfortunately, slower 

to seek medical attention at the time of a first heart attack because the disease is not one they expect to have. 

We want to see research on successful health education strategies for women. We must learn what motivates

women to seek information about heart health. Where and when do women get health information they believe

and incorporate into their daily lives? In the managed care era, we suspect that less education is provided by physicians in office visits that are shorter than ever. What are better substitutes? Will it be other health care providers, or

the media or volunteer organizations such as the AHA? A special group of women already available to help answer

these questions is the women who participate in cardiovascular clinical trials. Acquiring information about what

motivated each subject to participate may give us the insight we need to then target subgroups of women with 

similar characteristics for community programs.

New Mexico and Arizona have large populations of Native American and Hispanic women. Very little is 

known about the best strategies for heart disease prevention in these women. Ethnic differences exist in dietary

habits, diabetes incidence, smoking, and obesity. These differences must be understood if successful prevention

efforts are to be implemented.

Specific issues related to childbearing need to be addressed. Limited teratogenicity data are available about 

cardiac drugs that may be needed for specific situations during pregnancy. Minimal prospective, controlled-trial 

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data are available to guide anticoagulation decisions during pregnancy. A randomized, controlled-trial of heparin,

low molecular weight heparin, and coumadin should be designed and funded.

Basic research to elucidate gender differences in vasomotor tone and endothelial function should be supported.

Comparison of the effects on endothelium of estrogen, tamoxifen, and extreme cholesterol lowering by HMG CoA

reductase inhibitors is needed to enable the clinician to make informed therapy decisions with women who may

not be able to take estrogen after menopause.

In summary, we need to know who wants heart health information, how they want to get it, and what format

works best to promote behavioral change. The best strategies for prevention in Native American and Hispanic

women are unknown. Childbearing needs to become safer for women with heart disease who need drugs, especially anticoagulation. The endothelium will be final common target of what we suggest for women; we need to

know how to achieve, if possible, the same benefits seen with hormone replacement therapy in women who 

cannot or will not take estrogen.

Jeanne Carritt, M.A., M.Ed. and Lois Grey Long, R.N., M.S.N. Selves

The organization of this conference seems to preclude input from elderly women. Once women leave the

workforce, few have access to fax or e-mail. The titles and affiliations requested on the registration form represent

serious roadblocks for elderly women. Input about the elderly is, therefore, coming from younger people. Little

first-hand observation comes from the population who is coping with specific problems of the elderly. Some 

concerns of elderly women are as follows: 

1. In the agenda for this conference, elderly and frail elderly women were combined. Issues for women 

who are 65 or 70 and 85 or 90 years of age are enormously different. Since this is the fastest-growing 

segment of our population, it can only be ignored at the peril of society as well as of the women whose

problems we hope to address. This is a woman’s health issue because in the over 65 age group, women

outnumber men 2 to 1.

2. Considerable research on aging issues has been done, much of it on men. Generally the research has 

been divided by disciplines (e.g., one group working on housing and another on cardiovascular disorders).

The great need is to integrate these data and make information available between disciplines. We must 

find ways to provide reliable easy-to-understand information based on this knowledge to the general 

public and to the elderly and their families.

3. In this population, one cannot separate physical health issues from economic problems and from the 

components that make up psychosocial well being. Some of these are depression, poverty, and loss,

including those of mobility, friends, health, and general physical self confidence. Societal attitudes 
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toward women is a major concern that applies uniquely to women. All of these factors affect physical 

and mental health along with longevity and quality of life.

An example of a related economic concern is the cost of drugs. The current emphasis on treating osteoporosis 

in older women with the new medication, Fosamax, costs about $55 per month, putting it beyond the reach of

many women without insurance coverage or prescription coverage. The new sleeping medication, Ambien, costs

about $2 per tablet.

An example of maladaptive approaches to some of the losses is the increasing use of alcohol and mind-altering

prescription drugs to help cope with disturbed self concept and body image and the related stresses unique to

women. Elderly women are more likely to be prescribed drugs that affect judgment and safety, leading to yet 

greater health-related problems.

Many questions relate to the activities of daily living for which guidelines have not been established in the context of prevention for elderly women at any age. Available information is currently not geared to this age group.

In the parameters of “normal aging,” for example:

• How should diets be altered to accommodate metabolic changes and meet daily nutrition needs?

• Should older women use the same aerobic parameters currently standard for younger women?

• To what extent are dietary supplements and nutritional additives helpful or relevant?

Peripherally to women’s health, the change in living conditions brought about by women working outside the

home is creating change in the caretaking role, geographic disruption, and the demise of the extended family, all 

of which have changed the whole pattern of intergenerational living. These factors have created housing problems

of large proportions. Agencies that have attempted to address this issue are divided among city, state, and Federal

Governments. How can these services be integrated to best serve all ages and economic levels? As women become

much older and energies fail, must they attempt to navigate these various systems to get their needs met?

In addressing these problems, it must be understood that chronological age has little to do with functional 

status and with the kinds of support systems needed. There is a danger in standardizing services based on age

alone. Our current knowledge includes the information that each woman who reaches a certain age plateau can

expect to live x-number of years and be reasonably healthy. There is a lack of information about changes in 

services and support systems needed as these women become more frail.

With regard to the research focus of this conference, and in light of our original comment about obtaining

information on perceptions of needs from this most-advanced age group, perhaps the greatest challenge is simply

finding ways to elicit accurate information.

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Director of the Nutrition and Dietetics Training Program

Jean Charles-Azure, M.P.H., R.D. Indian Health Service

I am a member of the Lummi Tribe in Washington State. I also have Omaha, Ponca, and Sioux heritage.

Accompanying me is Carolyn Lofgren, Coordinator of the HQW Women’s Wellness Initiative and member of 

the National Indian Women’s Health Steering Committee. Our discussion focuses on nutritional issues related 

to Native American women’s health. 

As a Native American woman, I have long been interested in health care and health promotion for American 

Indian/Alaska Native (AI/AN) women. Native American women are concerned about their nutritional health

throughout the life cycle, especially in the childbearing, perimenopausal, and postmenopausal years. Many 

tribes are interested in resuming healthy nutrition and food traditions, such as breast feeding, lower fat cooking,

becoming more physically active, reducing risk for diabetes and osteoporosis, and achieving and maintaining

healthy weights. 

Native American women, often the decision makers regarding food selection and preparation, are committed 

to improving the nutritional health of their families and communities. They can be found leading community

efforts to provide healthy meals and physical activity for children and adults. They play a key role improving the

nutritional health through their active participation as parents and community members on advisory groups for 

day care centers, schools, Head Start, and elderly meals programs. Nutrition during recovery from substance 

abuse is stressed in the concept of a grassroots group, Gathering of Native Americans (GONA), “Indian Women 

in Action” support efforts. The community concept is making an impact in all areas of women’s health, but particularly in EtOH/Substance Abuse. Continued support for “community mobilization” interventions are essential 

for lifestyle changes and long-term outcomes.

The strategies developed to address the health problems of AI/AN populations need to consider the characteristics of the population. Over the past three decades, the nutritional health of AI/AN has changed dramatically

from morbidity and mortality associated with infectious diseases to chronic diseases associated with obesity. An

American Indian School Children Height and Weight Survey found that 40 percent of this population were obese.

Obesity has long been known as a major risk factor for cardiovascular disease, the number one killer of American

Indians and Alaska Natives. Another major consequence of obesity in children is the increasing incidence of Type II

Diabetes Mellitus, as early as age 14 years. Native infants who were breast-fed have been found to have lower rates

of diabetes than bottlefed infants. Native infants whose mother’s were obese during pregnancy have higher rates of

diabetes. Some American Indian Tribes have diabetes rates 10 times the rate of the U.S. population, virtually all in

Type II diabetes or diabetes in pregnancy.

Throughout the history of the U.S., AI/AN peoples have been an integral part of the American character. 

Tribal America has provided certain values and ideas as well as many native foods, that have become a part of 

the general American culture. Today, however, we see the health challenges facing American Indians. The 

research agenda for American Indians and Alaska Native women should consider these components:
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1. Community-directed pilot projects that rely on the public health model and foster partnerships between

community members and program staff to develop and implement nutrition and physical activity interventions. For the Indian Health Service (IHS), partnerships could include IHS, Tribal Programs, Urban

Indian Programs, Indian Community Colleges and Tribal Schools, Head Start, Food Distribution Programs on Indian Reservations, Women and Children’s Supplementary Food Program, Housing Programs,

Treatment Programs, Youth Programs, university research programs, and so on.

2. Information to learn the most effective public health strategies for reducing rates of chronic disease 

(diabetes, obesity, and cardiovascular) among Native women and in their communities. We need to 

know the key characteristics of the successful strategies for community mobilization, school interventions, worksite interventions, family interventions, multigenerational interventions, and nutritional 

interventions while respecting traditions, culture, and values.

3. Information dissemination to translate and transfer what is learned about successful interventions 

to other Native communities is an essential component of research projects.

Project Director for Women’s Health Coordination

Nursing Consultant to the Surgeon General on

Advanced Practice Nursing and Women’s Health

Col. Laurie Davis, Ph.D. U.S. Army Nurse Corp

Until 1994, the vast majority of research conducted within the military population has focused solely on military men with little to no research aimed at the female soldier. With the increase in numbers of military women

(340,000) and the expanded roles women are assuming within this predominantly male environment, it is vital 

that increased research emphasis be exerted towards this group. This need for increased research focus on military

women resulted in a 1994 Congressional directive which mandated that women be included in all DoD-sponsored

research. This directive was backed with a $40 million appropriation bill that enabled the establishment of the

Defense Women’s Health Research Center (DWHRC) for “multidisciplinary and multiinstitutional research” on 

military women’s health issues (Institute of Medicine, 1995). While this is a substantial initial step, much more

remains in addressing the multitude and variety of military women’s needs. This brief will present demographics 

of military women along with current research endeavors, and ongoing issues in need of continued and/or 

future research.

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National Coalition of Hispanic Health and 

Jane L. Delgado, Ph.D. Human Services Organizations (COSSMHO) 

I am pleased to provide the perspective of the National Coalition of Hispanic Health and Human Services

Organizations (COSSMHO) on the funding priorities for women’s health programs. COSSMHO is a private nonprofit organization representing the needs and concerns of 1,500 health provider members and the people they

serve. COSSMHO is the only national organization with a primary mission in Hispanic health. As a national 

organization, COSSMHO is unique in three major ways:

• Diversity is our strength. Since its founding in 1974 in Los Angeles, by two Mexican-American social 

workers and one Puerto Rican social worker, COSSMHO’s goal was to represent the needs of all Hispanic 

communities. The COSSMHO symbol represents the Mexican-American, Puerto Rican, Cuban, and Central 

American and South American communities joining hands to work together.

• Commitment to funding local programs. COSSMHO obtains funds for implementing model programs with 

local determination being the hallmark of our activities. Today 80 percent of COSSMHO’s budget is allocated 

to implementing multisite community programs. Approximately 50 percent of COSSMHO’s program dollars 

are awarded locally in the communities we serve. Our commitment to local determination is reflected in 

the positions we take as a national voice on Hispanic health policy issues.

• No funds from tobacco or alcohol companies. As the only national Hispanic organization with a primary 

mission to improve the health and well being of Hispanic communities, COSSMHO does not accept any 

funds from tobacco or alcohol companies or their subsidiaries. COSSMHO is the only national Hispanic 

organization to have adopted this policy. 

Hispanic Women and Research Issues. COSSMHO’s President and CEO, Dr. Jane Delgado, in association with 

the National Hispanic Women’s Health Initiative, has authored the first comprehensive compendium on Hispanic

women’s health. The book, ¡SALUD!: A Latina’s Guide to Total Health–Body, Mind, and Spirit, will be released by Harper

Collins Publishers in September 1997. In addition, COSSMHO has sponsored a university-based research consortium on Hispanic women’s health issues, in particular issues of chronic illness and access to health services for Hispanic women. COSSMHO also sponsors a number of efforts in the area of breast and cervical cancer early detection

and treatment. These efforts include the development of the Salud para Todas Breast and Cervical Cancer Resource

Kit and a model outreach program for community educators. In addition, Unidos por la Salud, a research network

of comprehensive cancer centers, is completing a landmark study of the treatment experiences of Hispanic women

diagnosed with breast cancer. This network is coordinated by COSSMHO with funding from the National Cancer

Institute and the NIH Office of Research on Minority Health. Women’s health has been a long-standing priority 

for COSSMHO.
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Director of Department of Services for Persons with Disabilities

Sally Esposito, M.S. City of New Haven

My department, the Human Resources Administration (HRA), is a division of the city of New Haven government. HRA includes Health, Elderly Services, Children and Family Services, the Fighting Back Initiative, and the

Welfare Department. The Health Department also includes Healthy Start and the Maternal and Child Health Outreach Program, the Mayor’s Task Force on AIDS, and the Ryan White Title II Program. The common denominator

among us is that we have a role in the provision or facilitation of services that impact the social and health needs 

of all New Haven residents. 

New Haven is a diverse city best known, perhaps, for its medical and health facilities and services, and for a

steadily growing biomedical technology industry. The population of New Haven is declining. In 1995, the population of New Haven was estimated to be 123,770, although the U.S. Census Bureau estimated the 1995 population 

to be as low as 118,000. Although Connecticut had only 5 percent of its population living below the poverty level 

in 1989, New Haven’s rate is four times higher at 21 percent. The distribution of that poverty is particularly hard

on female-headed households. In general, 65 percent of New Haven families are headed by women who live in

poverty. They also are the population group with the least access to cars and telephones, without which scheduling and attending medical appointments is tremendously difficult in New Haven. 

Although New Haven is home to a tremendous number of health resources, as a community, we do not have 

a comprehensive, planned, identifiable public health policy on women’s health, nor do we even have an informal

priority to identify gaps in services and specific strategies for women. Human or financial resources have not been

available to study women’s health needs as they should be studied. 

We have the infrastructure for and do collaborate on many health matters, but we need to do more in the area

of women’s health. We are interested in developing a women’s health agenda starting with a formal assessment of

New Haven women and their health needs. In addition, we wish to capitalize on existing successful grassroots

efforts to reach women in their respective environments. 

Specific needs of women with disabilities are even harder to determine. How many women with disabilities 

are there? How many are victims of domestic violence in New Haven? Those in positions to estimate do not agree

on the numbers of people with disabilities. Do we use the Census Bureau’s definition, the definition of a person

with a disability included in the Americans with Disabilities Act, the Social Security Administration’s definition, 

or self-identification by an individual. We do not have good information on the numbers of people with disabilities 

or, in fact, do we have a commonly understood definition of disability. We need to address these issues and find

out who and where these women with disabilities are. We need to do all this on the national level, but it is even

more urgent on the local level where we are the people that those in need first find. 

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Cordelia Gilkyson, C.M.T. The Endometriosis Association

Endometriosis is a condition that affects millions, or approximately one in six women that we know of in

North America and countless others all over the world. Little help has been available until very recently. For what 

I had a minor laparoscopy and laser surgery for, some doctors are still prescribing hysterectomies and extreme hormone therapy treatments, which often create more side effects than the endometriosis itself. Thousands of women

are walking around in pain today not knowing why, and very often being misdiagnosed or mistreated by their doctors, for lack of information on causes and treatments. There are no known causes for endometriosis, only theories

by the women who have experienced it in their own lives. It is greatly affected by diet, lifestyle, and state of mind

as so many health issues are, but one often wonders about the effects of our environment on the sensitive reproductive systems of women. 

Treatment options are limited. It must become a topic that is discussed within school systems’ health programs, that is required continuing education for MDs and OBGYNs, and that has readily available information 

for the public. 

We need more research into the effects of our environment on women’s health, primarily chemical exposures,

household and cosmetic product ingredients, foods, pesticides, and all potentially toxic or hazardous compounds.

Despite limited scientific information, there is evidence of the reproductive toxicity of some substances in wide

commercial use. Some studies have shown dioxins and PCBs to be directly linked to endometriosis and infertility,

as well as some 45 chemicals widely distributed to the U.S. government, including 35 pesticides and ten industrial

chemicals as shown by a study done by the University of Wisconsin. These same chemicals can damage one’s body 

by imitating natural hormones, binding to receptors on fetal cells and altering the genetic instructions. These 

imitations can then potentially “derail” human development, permanently distorting its reproductive system.

Knowledge is the first step. Educate our doctors. Continue research on causes and treatments. The Endometriosis Association reports that 70 percent of women diagnosed with endometriosis were initially told by their 

doctors that there was no physical reason for their pain. Of women of color diagnosed, 40 percent were told 

they had a sexually transmitted disease. 

The prevalence of endometriosis is rising in younger women, but few of them know what they’re dealing 

with or how to begin to treat it. Although the condition affects millions of people, it does not garner the resources 

that more lethal diseases do. Between 30 and 40 percent of women who are treated for infertility have endometriosis. Knowing that endometriosis is one of the leading causes of infertility, I would like to see more funding 

allotted towards research in the areas of fertility, environment, and women’s health. 
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Linda A. Gonzales, M.A. Consultant, New Mexico Disability and Health Program

Health issues for women with disabilities are the same as for all women. They are concerned about pregnancy,

breast and cervical cancer, diabetes, aging, osteoporosis, high blood pressure, stress, and heart disease. They need

to be concerned about weight, nutrition, and exercise. The difference is the ongoing presence of a major disability

around which these health concerns constantly revolve. If these health concerns become health conditions, they

are, in fact, secondary to the primary disability. Secondary conditions is a term that is relatively new to persons

with disabilities. The list of health concerns includes: 

1. Conditions that may be a direct result of the disability such as dicubitus ulcers, spasticity and urinary 

tract infections in women with spinal cord injury, or memory loss or disorientation in a woman with 

a head injury.

2. Conditions that may be exacerbated or more likely to occur as a result of the primary disability such as

weight gain, high blood pressure, poor circulation with mobility impairments. Examples of the disabilities

that invite a more sedentary lifestyle include blindness, amputation, kidney failure, and other secondary

conditions in a woman with diabetes.

3. Conditions that extend to environmental factors include a woman with a severe hearing impairment 

or deafness who cannot adequately communicate with her doctor, a woman who skips her annual 

pap tests because she can no longer get up on the examining table, physicians who no longer weigh 

their patients in wheelchairs.

4. Conditions that occur as a result of living with a disability in an able-bodied world, such as being different, feeling devalued. These women have a greater potential for greater stress, depression, isolation, and

feelings of loss, anger, and resentment. They must deal with issues of attractiveness, self esteem, and 

social interaction.

The disability causes a strain on relationships, sexuality, and child rearing. 

Research issues for the future include obtaining baseline data on secondary conditions in women with disabilities:

• Women who use wheelchairs. Are they receiving primary and preventive care and screenings at the same rate 

as the general population of women? (1993 DHP survey says they are not.)

• What are the risk factors related to common secondary conditions in women (i.e., dicubiti, UTI)? Research is

needed to provide for information on alternative methods of preventing the recurrence of these conditions.

• What are the reproductive and aging issues for women with disabilities?

• What impact do lifestyle changes have on women who become disabled over a period of time? (i.e., sedentary, inactive, less mobile). Are these women more predisposed to acquiring chronic conditions because of 

these changes? 

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• Identify areas of collaboration and work with scientists/researchers in other areas of disability rehabilitation

(NIDRR, RSA) and disability and health (DHHS: CDC grants to 15 states to develop a scientific base of information for the disability population). Women’s health issues are a priority in many states. Also, identify any

other areas where research efforts may overlap.

• Conduct policy research on health services/providers and public recreational/physical fitness facilities that 

readily accommodate people with disabilities. What impact do these factors have in the overall health and 

wellness of women in particular (i.e., gynecologists, clinics, women’s fitness programs)?

Women with disabilities must be involved in all aspects of research planning and implementation. The disability rights and independent living movements stress the value and importance of consumer involvement. Be

aware that people with disabilities are proactively concerned about and involved in the future of their health care:

managed care, the right to die movement, organ donor priorities, assisted suicide, and women’s health issues.

Janet Greenwald Citizens for Alternatives to Radioactive Dumping

Since the beginning of the nuclear age, over 50 years ago, women and children and veterans have paid a 

heavy price in terms of health for whatever security we gained through the development of the bomb. Though 

the plutonium experiments were brought to the nation’s attention by the Albuquerque Tribune, the stories of 

the survivors of uranium mining, workers at Los Alamos, atomic veterans, and downwinders are little known.

Through my 17 years of experience in dealing with these survivors, along with my association with researchers 

and health professionals concerned about this issue, I have what I believe is interesting information, both 

scientific and anecdotal.

Barry Halber, M.P.A. Wilbar Health Productions

For more than 30 years, research dollars have been spent in the U.S. and other countries concerning the 

problems associated with choosing hysterectomies. However, by age 60, one in three American women have 

had their uterus removed (Italy, 1 in 6; France, 1 in 18); that is 560,000 women a year at a cost of $3 billion.

Women today are not fully informed concerning these problems and options; that the public health (physical

and emotional) and economic impact of these decisions are staggering with enormous quality of life implications 

for the 21st century woman in the United States.
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Women’s decisions may reflect a gap in knowledge due to a lack of easily understood information, population 

differences, race, culture, ethnicity, and economic factors that impact their interaction with physicians. Someone

should pull together the various reports and findings and make them available (i.e., annotated bibliography) 

on a continuing basis to women of all ages through regional and local organizations (i.e., educational, social, 

health, business).

More importantly, information should be widely disseminated to all women in an easily understood format 

so that these basic comparative charts illustrate differentiated symptoms, diagnostic techniques, assessments, risks,

treatment options, self-help programs. Each woman can utilize these charts to reflect more carefully, openly and 

privately with their physicians and family members. A toll-free telephone number should be activated by the 

NIH Office of Research on Women’s Health and encourage the participation of the College of Obstetrics and 

Gynecology and the American Academy of Family Practice.

Local physicians should be encouraged to participate in local and regional seminars and discussions with 

interested and concerned women and family members. This might coincide with the ten regional HHS offices and

include a collaborative effort of national health foundations that share these interests (i.e., the Robert Wood Johnson Foundation, the Henry J. Kaiser Foundation). Dissemination of information should include a full spectrum 

of local organizations. New research findings should be updated annually and made part of this continuing effort.

Ladies and gentlemen, we are accountable as individuals and through our organizations for both our commissions and omissions. With this cooperative and focused approach, our efforts can be both feasible and successfully

implemented so that women can have truly informed choices.

Albert C. Hergenroeder, M.D. Baylor College of Medicine

There are gaps in our current understanding of prevention of osteoporosis with respect to young women and

hypothalamic amenorrhea/oligomenorrhea, including women with eating disorders and athletes. These include:

1. The vast majority of bone mineralization in females occurs by the middle of the second decade; however, 

the normal acquisition of peak bone mass in late maturing and minority females has not been established.

2. Even though osteoporosis is not as great a problem in the African-American female population as it is 

in the European-American population, it is nonetheless a problem and there is no research addressing 

the natural history of bone mineral acquisition in young African-American women at risk for premature

bone mineral loss. 

3. Premature bone demineralization occurs in women with hypothalamic dysfunction manifest as amenorrhea

and oligomenorrhea, associated with athletics, dancing, and eating disorders. Bone demineralization will 

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be occurring soon after the amenorrhea develops. Treatment to prevent premature bone loss and promote

bone mineral accretion should begin soon, probably within 6 months after amenorrhea occurs. However,

the criteria to commence estrogen replacement therapy in young women are not established. The information available is from European-American women receiving short term therapy. 

4. Women who recover from anorexia nervosa at a young age (<15 years) can have normal total body bone

mineral, but regional (lumbar spine and femoral neck) bone mineralization may remain low. The longer the

anorexia nervosa persists, the less likely it is that the bone mineral will return to normal. Females with anorexia nervosa need to be rehabilitated early in the disease to maximize bone mineral accretion. Currently a

gap exists in available knowledge and its application in practice. Physicians and other health care providers

need more training in recognizing women at risk for premature bone loss and advising them accordingly. 

5. Conjugated estrogen, in doses that improve bone mineralization in postmenopausal women and in combination with medroxyprogesterone, has not been shown to consistently improve BMD in young women

with hypothalamic amenorrhea. Treatment with oral contraceptive pills has been demonstrated to have a

beneficial effect on bone mineralization in young females with hypothalamic amenorrhea, however long

studies with an amenorrheic and oligomenorrheic subjects are needed. 

6. Osteoporosis is a major cause of morbidity and mortality. Peak bone mass is a major determinant of 

the risk of osteoporosis and the second decade is the critical period of peak bone mass acquisition; 

thus those who provide health care for adolescents and those concerned about preventing osteoporosis 

need to join forces to understand the factors which affect bone mineralization during this period and 

develop long-term treatment strategies. 

Penelope Kegel-Flom, Ph.D. Association for Women in Science

ORWH was charged to “increase the number and enhance the career development of women in biomedical 

science.” The Association for Women in Science (AWIS) is a professional society dedicated to “achieving equity 

and full participation for all women in science and technology.” As past president of AWIS, I want to tell you about

AWIS’s recent study, “Cultivating Academic Careers: Warming up the Chilly Climate for Women in Science,” funded

by the Alfred P. Sloan Foundation. 

The AWIS study identifies barriers to the recruitment, retention, and advancement of women scientists. Strategies for eliminating these barriers, and thereby “warming up” the chilly climate for women scientists, are among

AWIS’s recommendations. Dissemination of our findings, we anticipate, will help institutions and government agencies, such as NIH, change the environment for women scientists in ways that will increase their entry into science

and advancement in their careers. 
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Differences in the academic advancement of women scientists are well documented. Compared to male colleagues, women scientists are paid less, promoted less often, more likely to be unemployed or underemployed,

receive fewer prestigious awards, participate less in science policy and funding decisions, and are, overall, sparse 

at the top. Cited reasons for these disparities are: lack of mentoring from senior scientists; exclusion from the 

inner circles of departmental politics and influence; isolation; conflicts between professional and personal lives; 

and frank gender bias.

Academic climate for women scientists was the focus of the AWIS research. Onsite visits were made to the 

biology, chemistry, and mathematics departments of three different institutions: Large Public Research University,

Small Liberal Arts College, and Historically Black University. Visits were preceded by assessment of institutional 

policy regarding recruitment, hiring, and promotion of women faculty, and by in-depth surveys of science 

faculty and students. 

What did the AWIS study find? First, issues related to barriers for women were identified: department recruitment and hiring practices, tenure and promotion, mentoring, family and work, communication between faculty

and administration, informal networking, and university-supported initiatives for women faculty. These issues

applied regardless of size or character of the institution. Second, strategies to address these issues emerged. For

example, recruitment and retention of women scientists, we found, requires establishing clear departmental goals

and timetables for recruitment and hiring, designating slots for women, equitable hiring packages, and departmental accountability for improvement in hiring and retention of their women scientists. In addition, the institution

needs policies that change, i.e., “warm up” the environment for women scientists. Adequate child care services, 

flex-time, family leave, extended time to tenure, dual career and joint position options, and spousal hiring policy 

and procedures are essential. Students in particular emphasized that their willingness to enter and continue in 

a science career depended on being able to have a career and a family, without “penalty” in their careers.

The issues raised in the AWIS study reflect those reported in other studies; together, the message is resoundingly clear: equity for women is more theoretical than actual.

ORWH of NIH has provided strong national leadership for change in research on women’s health. NIH can 

also lead the nation in the direction of major climate change in the science workplace, one that will benefit all 

scientists. NIH can ensure: (1) that its intramural research programs create and maintain environments that 

eliminate discrimination; it can mandate “policies-without-penalty” that allow flexible work schedules, family 

leave, and dual career opportunities; (2) that women and minority scientists are aggressively and equitably recruited, hired, and promoted; (3) that external training programs for young scientists and health professionals expand;

and (4) increased visibility of its women and minority scientists, particularly through appointment to top-level,

decision-making positions.

More women and minorities will enter and advance in science careers as NIH continues to initiate a 

change in climate. And, as with the Women’s Health Initiative, others will again follow the lead of the National 

Institutes of Health.

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Gwendolyn Puryear Keita, Ph.D. American Psychological Association

The APA would like to convey its deep appreciation for Dr. Pinn’s recognition of the importance of psychosocial and behavioral factors in women’s health and the inclusion of behavioral and social scientists in the development of the new women’s health research agenda. We are the largest scientific and professional organization 

representing psychology in the United States. APA’s membership includes more than 151,000 researchers, educators, clinicians, consultants, and students. APA has a long history of involvement in women’s issues, in particular 

supporting and encouraging behavioral and social science research to address women’s health.

Despite increased focus on medical and epidemiological aspects of women’s health, research has not adequately

addressed psychosocial and behavioral factors that contribute to health status. In May 1994, APA, in collaboration

with a number of federal agencies and professional organizations, sponsored an interdisciplinary conference titled

“Psychosocial and Behavioral Factors in Women’s Health.” The purpose of the conference was to highlight the

extensive research implicating behavioral and psychosocial factors in a number of major chronic diseases and 

conditions that influence women’s health across the life span.

The “Research Agenda for Psychosocial and Behavioral Factors in Women’s Health” evolved out of the conference. It was developed by the conference advisory committee, which included experts from across disciplines, 

institutes, and federal agencies — including ORWH — and represented a broad range of women’s health concerns.

The Research Agenda builds on the growing body of knowledge in women’s health and articulates a set of priorities

for the next generation of research studies. 

The Research Agenda defines research priorities pertaining to specific diseases and health practices that 

greatly affect women. The diseases included are those that show high mortality or morbidity rates for women 

and that may cause great physical disability, lowered financial resources, and poorer quality of life. Some of 

the priorities delineated support important priorities for women’s health identified at the beginning of this 

decade in the U.S. Department of Health and Human Services’ Healthy People 2000.

APA believes that consideration of future research and funding needs for women should be made 1) with 

full awareness of the issues of concern to women’s health, 2) with knowledge of what research has already shown, 

3) with knowledge of what questions remain unanswered, and 4) with a full appreciation of the behavioral and

psychosocial factors that impact each health issue. Our Research Agenda was developed with these factors in 

mind. We, therefore, propose that ORWH use our Research Agenda as the foundation upon which ORWH builds 

its new research agenda. This would avoid duplication of efforts and enable women’s health researchers, federal

agency personnel, and policy makers to most effectively address women’s health research and would go a long 

way in furthering the much-needed federal commitment to improving the health of America’s girls and women.
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Daniel Kerlinsky, M.D. Physicians for Social Responsibility

The Environment Committee of Physicians for Social Responsibility, a national organization of 15,000 members, supports the prevention of nuclear war, reduction of violence, and the protection of the global environment.

The organization is particularly concerned with the effects of toxic environmental chemicals during the prenatal

period. The issue of environmental toxicity in the prenatal period is important to ORWH for several reasons:

• Toxic exposures during fetal development produce effects that last a lifetime. Birth defects, mental retardation,

and impaired reproductive ability are some of the lifelong effects of in utero exposure to toxins. Each of these has

profound impact on self esteem, social functioning, vocational abilities, and family life. The more subtle toxic

effects on information processing, emotional relatedness, attention and aggressive behavior may be difficult to 

study. Having a single, handicapped child changes every aspect of family life. However, toxic environmental 

exposures are likely to produce multiple lifelong impairments in several children in the same family.

• Sensitivities during this period are orders of magnitude greater than in later life. The developing fetus is much

more sensitive to toxic chemicals than adults are. Dioxin exposure shows that regulatory genes, growth factors, 

protein transcription, and multiple hormone systems can be affected by these chemicals. These effects can

occur at very low concentrations. Hypoplasia, a decrease in cell numbers, occurs in lymphoid tissue; dysplasia,

the abnormal growth or development of an organ, occurs in ectodermal tissue in humans. It is not necessary 

to kill a cell during fetal development to affect brain development; an impaired energy metabolism in a cell 

may be sufficient to lead to altered connections. These sort of effects appear functionally years later when 

complex functions, such as sustained, voluntary attention, require the coordination of many brain areas.

• Multiple organ systems are affected by prenatal toxins. Many organ systems are affected by exposure to toxic

chemical exposure in utero. This leads to more complex illnesses, such as asthma, disorders in liver metabolism, and multiple drug sensitivities. Immune system suppression may further complicate the presentation 

and management of these cases. 

• Women bear the brunt of raising CNS and behavior disordered children. Mothers are directly impacted by 

the behavior problems of their children. The increased stress that these children experience in their early 

years may be followed by physical traumas as they get older. Male children exposed to toxic chemicals 

show increased aggressive behavior as they enter their teenage years.

• In utero exposure to environmental chemicals may have profound effects in wildlife populations, which may 

in turn, affect human populations. Population reductions in wildlife due to reproductive failures have been 

profound. Decreases of 80 percent in populations of birds and mammals over just a few years have been

reported. These raise concerns about human reproduction as humans are not particularly resistant to the 

toxic effects of the chemicals to which these population crashes are attributed.

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• Proposed solutions to dealing with the threat of prenatal toxins include regulating and restricting the use 

of toxic chemicals; long-term research support; medical and community education efforts; and government 

outreach and support to women whose occupations expose them to toxic chemicals.

Wilhelmina A. Leigh, Ph.D. Joint Center for Political & Economic Studies

My statement addresses population differences due to race/ethnicity and their influence on women’s health.

One health behavior (help seeking in the managed care environment) and several health outcomes (low birth

weight, hypertension, osteoporosis, and Alzheimer’s disease) are the specific foci of my statement. The following

questions summarize my statement. 

• Health behavior: How will populations with little education, little knowledge of English, and little knowledge 

of health conditions, recommended preventive tests, and the like, respond in the managed care environment?

• Low-birthweight infants: How is the incidence of low-birthweight infants born to African-American and Asian

Indian women explained? What are the protective factors for births to first generation Mexican-American women?

• Hypertension: What physiological and psychosocial mechanisms underlie the high rates of hypertension, 

heart disease, and death among African Americans, Native Hawaiians, and Filipinos?

• Osteoporosis: Is childhood nutrition implicated in osteoporosis? What behaviors and factors could be preventive

for osteoporosis among Asian women, among whom the incidence is high?

• Alzheimer’s disease: What is the relationship between the incidence of Alzheimer’s disease and aging among

women of color? Are the oldest old women of color more or less likely to get the disease than younger old

women of color?

Susan Lewis Independent Living Research Center

As a woman with a spinal cord injury (quadriplegic) there are many areas or gaps in knowledge relating to

health for women with disabilities. After sustaining an injury at 24 (a time when thoughts of education, careers, 

marriage, and families enter the picture), I entered a different world. A world where my independence 

and freedom were taken away from me.
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The medical professionals did not provide the needed information, education, or financial resources necessary for transitioning me from the hospital back into my home. As a result, I ended up in a nursing home for 

8 years of my young life. I lost control of every aspect of my life. 

After the assistance, support, and encouragement from an employee of the Division of Vocational Rehabilitation I was able to move out of the nursing home and return to school for an education. 

Living in the community and regaining my independence I have learned that the following issues affect 

women with disabilities:

• Lack of information for individuals and their families. Increasing information increases choice and 

individual empowerment.

• Adaptive equipment is not always accessible and is often times very expensive. Having access to 

adaptive equipment eliminates limitations.

• More services are needed, especially at the initial phase of an injury. Attendant services are of major 

importance but in most cases not easily accessible or affordable. They are important in maintaining 

quality of life and for reducing risk of developing infections and other health problems.

• Health and Auto insurance issues faced by women with disabilities. Auto insurance increases because 

of being a “high-risk” driver, and health insurance is not always accessible. If it is, there is no guarantee 

that it will assist with payment of medical assistance.

• Women with disabilities face extreme financial issues. The cost of living with a disability puts extra 

stress on individuals and families.

• Complicating the issues of women’s health is the fragmentation and under funding of a variety of federal 

and state programs that pay for a range of services that people with disabilities need to become independent. In addition, more of these programs contain disincentives to employment, which keeps women 

with significant disabilities out of the work force and dependent on services and programs.

These are just a few issues that women with disabilities face living in our communities. These areas need 

to be addressed so those women with disabilities can live a quality life in our communities. 

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Washington, D.C. Liaison

Rosemary Locke Y-ME National Breast Cancer Organization

In 1996, Y-ME National Breast Cancer Organization and other cancer patient and provider organizations filed 

a citizen petition urging the Food and Drug Administration (FDA) to ease its restrictions on access to silicone gel

breast implants for women with breast cancer or those at high risk for the disease. The petition relied on the

impressive body of sound scientific evidence related to silicone gel implants that has been produced since the 

FDA severely limited access to these medical devices 5 years ago.

Women requiring mastectomies following a diagnosis with breast cancer face the difficult and very personal

decision whether to have reconstructive surgery. Y-ME and others strongly believe that women with breast cancer

have the right to choose whether they want implants and to select the product that will give the best cosmetic 

outcome for reconstruction. In order to make this decision, we must have as much clear and accurate information about the safety of these products as possible.

Unfortunately, women have great difficulty obtaining accurate information. Many women increasingly rely on

the media to assist them in making health related choices. But sadly, for the most part, the media has presented

sensationalized stories about women with breast implants using anecdotal accounts instead of scientifically valid

studies looking for a causal relationship between breast implants and illness.

FDA, the source informed consumers should normally rely on, continues to downplay the overwhelming 

scientific evidence that indicates no clinically relevant risks associated with these devices. Moreover, two official 

FDA documents send a mixed message to consumers. This creates fear and confusion for women considering

implants as well as those who already have them.

FDA breast implant policies have broader implications relating to the regulation of and access to medical

devices used in the treatment of other cancers. The threat of overly burdensome regulations and litigation have 

an intimidating effect on the research and development of potentially life-saving medical products.

Because the FDA failed to address adequately our concerns, the following cancer organizations joined Y-ME 

in the attached citizen petition: American Cancer Society (ACS), American Society of Clinical Oncology (ASCO),

Cancer Care, Inc., Candlelighters Childhood Cancer Foundation, National Alliance of Breast Cancer Organizations

(NABCO), National Coalition for Cancer Survivorship (NCCS), Society of Surgical Oncology, and US TOO International (prostate cancer organization).

We believe that this document will provide a valuable tool for the Office of Research on Women’s Health as 

it assesses issues relevant to breast implants, other medical devices, and scientific research. 
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Ann Martin-McAllen, M.S., Ph.D. (Candidate) Self (Presented by Sheena Cameron)

Fibromyalgia is a topic of importance to women’s health. I am currently studying the connection of stress, 

personality and coping style in women who have been diagnosed with fibromyalgia syndrome (FMS) for my 

dissertation. I also am an FMS survivor. 

I was diagnosed with FMS numerous years after several traumatic experiences, two of which were automobile

crashes. I experienced many problems in trying to get a diagnosis — I saw many doctors of various specialties, had

many examinations, took a great variety of tests, yet they stubbornly refused to believe that it was anything but just

my imagination, because I “looked perfectly healthy.” Before obtaining a diagnosis, I had gained 80 pounds, was 

so fatigued at times that I could hardly function, was in tremendous pain throughout my body which at its worst

caused me to depend on my husband to perform almost every task of daily living. 

Once diagnosed I knew I had achieved the first step in regaining my health or at least becoming functional

again and hopefully would be able to recapture my life and my future. What followed my diagnosis was a continued quest for treatment modalities that would restore my health or at least allow me to reclaim my life and 

my relationships. 

FMS is defined as “a form of nonarticular rheumatism characterized by widespread musculoskeletal aching 

and stiffness, as well as tenderness on palpation at characteristic sites called tender points.” 

FMS occurs predominantly among females, with only 5 to 20 percent of the cases among males. FMS occurs

most commonly in the age group of 30 to 50 years, but some juveniles and elderly also are afflicted. Most patients

are Caucasian, but FMS is also found among the Japanese and South African blacks. 

The reason this syndrome is of such concern is that FMS dramatically affects the lives of its victims in a wide

range of ways. The range of impairments include: muscle pain, functional disability, poor physical fitness, work 

disability, psychological distress, decreased quality of life, and relationship problems. The lack of information and

understanding by the public and the health care community has caused many women to suffer needlessly, virtually

having their lives destroyed. Women have been told and are still being told that there is really nothing wrong with

them because nothing shows up in tests and they look well. This attitude has caused family members to doubt 

the seriousness of the condition and this only adds further suffering to the individual. 

In summary, millions of women suffer from FMS. Many have been unable to obtain a diagnosis because of 

the confusion within the medical community regarding FMS and the stigma that still exists where women’s health 

is concerned. Thus we must call for a greater focus in research of the etiology and treatment of FMS. We have a

responsibility to take women seriously, believe them, and trust that they know their bodies; to not dismiss their

complaints as being neurotic. This can begin with the use of behavioral medicine. Using behavioral medicine,

women can be taught to recognize how their behavior affects their lives and their health especially; how our 

culture affects our attitudes and that we as women do have choices in our behavior.

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Chair

Ann McCampbell, M.D. Multiple Chemical Sensitivities Task Force of New Mexico

I am a physician disabled with Multiple Chemical Sensitivities (MCS). I am also the Chair of the Multiple 

Chemical Sensitivities Task Force of New Mexico, a statewide advocacy organization for people with MCS. 

Because this illness primarily affects women, I encourage the Office of Research on Women’s Health to make 

research on MCS a high priority.

In-depth research on MCS is urgently needed and long overdue. Since MCS was described in the 1950s, 

its prevalence has grown to near epidemic proportions, yet this illness continues to be virtually ignored by the

medical and scientific communities. The fact that the vast majority of MCS sufferers are women has undoubtedly

contributed to the tendency for MCS to be dismissed as hypochondriasis and hysteria. Efforts by the chemical

industry, with its vested interest in maintaining doubts and controversy about MCS, have also contributed to lack 

of research in this area. Clearly, it is time for government to declare war on MCS, as it has on cancer, and commit 

to solving the mysteries of MCS, developing effective treatments, and implementing prevention programs. 

Associate Director

Martha A. Medrano, M.D., M.P.H. Medical Hispanic Center of Excellence

We have organized a Hispanic Faculty Association within our institution to identify and address issues 

of Hispanic Americans. The issues we have identified for Hispanic women in academia are as follows:

• Early in their careers, Hispanic women faculty are heavily involved in clinical services and not having 

an opportunity to be involved in activities that will assist their tenure and promotion.

• Hispanic women faculty are sometimes written into grants requesting funding to research Hispanic 

communities, but have limited influence in the project. When the grant is funded, they are not notified 

and therefore not involved in the project.

The solutions to the above issues are:

• Funding of postgraduate fellowship opportunities for women of color in academia.

• All grants targeting research in minority populations should have, at a minimum, one co-investigator involved

through the life of the grant, who is representative of the population being studied. This would ensure sound,

culturally and gender sensitive research design, methodology, implementation, and reporting of results. This

would also assure that female minority researchers have opportunities to be involved in research projects. 
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Holly Neckerman, Ph.D. Navajo Division of Health

It is essential that the health concerns of the Navajo woman are heard. The Navajo Nation stands out from

other Indian tribes and other ethnic groups. For the most part, Navajo people are both physically and geographically isolated. To fully appreciate the urgency of the health problems affecting the Navajo women, it is essential 

that you understand who the Navajo people are and the conditions in which they live. The Navajo Nation is the

largest American Indian reservation in the United States, yet many people lack complete plumbing or kitchen 

facilities, or working telephones. The rates of unemployment and poverty are much higher than other parts of 

the country and other ethnic groups. Four health issues are of critical concern: gestational diabetes, chlamydia,

breast and cervical cancer, and domestic violence.

Gestational diabetes. Research and clinical practice indicate that gestational diabetes is an urgent problem 

among Navajo women. One study found that the prevalence of gestational diabetes was 3.4 percent. Currently, 

there is no coordinated effort to provide adequate education, recruitment, monitoring, and followup for women 

with gestational diabetes. The Navajo Nation is seeking funding to develop a coordinated, comprehensive, and 

multidisciplinary approach to patient education, recruitment, and care to women with pregestational and 

gestational diabetes.

Chlamydia. Although the number of syphilis and gonorrhea cases has decreased since 1975, chlamydia is 

fairly new to the Navajo Nation. In 1986, there were 44 cases and in 1996, there were 1,305 cases. The Navajo 

STD Program provides STD/HIV counseling, referral for STD testing, and HIV testing and treatment referrals. 

While they do conduct surveillance activities, they are a paper-and-pencil operation. Our recommendations 

include more up-to-date treatments and more prevention education aimed at young adults.

Breast and Cervical Cancer. The incidence rates for breast and cervical cancer are not higher than other 

ethnic groups across the United States, yet the 5-year survival rate is much lower because of the advanced 

stage of the disease upon detection. One year ago, the Navajo Breast and Cervical Cancer Project was funded 

by the CDC. We are moving forward with a plan to increase access and availability of breast and cervical cancer

screening among older, underserved women with the hope of saving lives and increasing survival rates. 

Domestic Violence. Domestic violence is a clear problem among Navajo women and demands a collaborative and comprehensive solution. In an area with too few police to cover such a large geographic area and too few

people having telephones to call for help, there is really a need to go beyond the criminal justice model for the prevention of domestic violence. The Department of Social Services has funding to tackle the criminal enforcement

aspect of this problem, yet we need a comprehensive approach to address the problem in its entirety. 

Like the rest of the United States, we must move beyond a piece-meal approach towards the understanding, 

prevention, and treatment of women’s health issues. Yet an additional problem impedes progress. There is a severe

shortage of Navajo medical, health, and research professionals. Additional training opportunities will give the 

Navajo people the necessary tools and knowledge such that they can come to the table to voice the concerns, 

ideas, and visions for the good of the Navajo people.

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Women’s Health Center of Excellence

Electra D. Paskett, Ph.D. Bowman Gray School of Medicine

Approximately one million persons in the United States are diagnosed, and over one-half million die 

of cancer each year. A disproportionately greater number of incident cases and deaths are among the socioeconomically disadvantaged.

African Americans comprise about one third of the poor and have the highest overall age-adjusted cancer 

incidence and mortality rates of any population group in the United States. Of particular concern are breast, 

cervical, and colorectal cancer since screening exams, when used regularly, can reduce mortality.

Research conducted by investigators at the Women’s Health Center of Excellence at the Bowman Gray School

of Medicine have focused for several years on improving rates of screening exams among low-income, predominately African-American women. One of the most recently completed studies, the Forsyth County Cancer Screening Project, was an NCI-funded study to improve breast and cervical cancer screening among women who resided

in low-income housing communities. The end of study survey collected information on knowledge, attitudes, and

practices related to breast, cervical, and colorectal cancer. These data provide insight into differences in screening

behaviors among African-American and white women who have a relatively similar low socioeconomic status.

A random sample of 424 women, stratified by city and age group (40 to 64; and 65 and older), from the 

housing communities was selected to participate in the end of study survey by simple random selection. Of the 

300 women who participated in this cross-sectional survey, 79 percent (N=237) were African American and 

21 percent (N=63) were white. African-American women in the sample were younger (average age 66 years) 

compared to white women (average age 73 years) (p<.001).

In general, screening tests for breast, cervical, and colorectal cancer were underutilized by the women and 

racial differences in screening rates were observed. Only 52 percent of African-American women and 40 percent 

of white women had had a mammogram within recommended age-appropriate guidelines. About 60 percent had

had a Clinical Breast Exam in the last year although about 80 percent had visited a physician in the last year for 

a regular check-up. Fewer white women had had a Pap smear in the last year, but African-American women had

achieved the 80 percent goal set by the year 2000 objectives. Colorectal cancer screening test utilization rates were

low among both groups of women. After adjustment for significant factors, important issues related to obtaining

regular screening exams included the receipt of regular check-ups, and knowledge, beliefs and barriers related to 

the specific screening test regardless of race. These data suggest that efforts to improve mortality rates from these

cancers among low-income women should include tailored messages to improve beliefs and convey understanding 

of risk. These efforts will assist in bringing us closer to the Year 2000 goals for all women and help to reduce 

the disproportionate cancer mortality rates among low-income populations.
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Sally Piscotty The National Association of Women’s Health Professionals

The National Association of Women’s Health Professionals (NAWHP), a membership organization of 

women’s health administrators, health educators, and clinicians, works at the local level to disseminate the 

results of scientific studies and to provide gender expertise in the treatment and education of women.

NAWHP recommends that research be conducted to examine:

• The effectiveness of health education methods, focusing on the role of psychosocial determinants 

of effectiveness.

• The risks, benefits, and effectiveness of alternative medicine practices.

Health education. Information and health education can enable a woman to avoid major risks, practice prudent self care, and seek timely medical interventions. Members of NAWHP and others across the country who 

are measuring the effectiveness of their health education programs have found that they not only improve the

health status of women, but that they also reduce long-term health care costs. For example, a breast health education program offered by St. Charles Medical Center in Bend, Oregon has successfully demonstrated that education and community outreach has resulted in early diagnosis of breast cancer with a 75 percent Stage I diagnosis 

as compared to a national average of 49 percent. The cost of treating one early-stage breast cancer is approximately

$12,000; late-stage treatment is estimated at $145,000.

While the impetus and purpose of many women’s health centers, clinics, and service lines is to help women 

to be informed health care consumers and to give them the knowledge they need to take care of themselves, we

currently teach women about their health without scientific evidence regarding the suitability or effectiveness of 

the education. Studies suggest that women learn differently than men and that behavior change is elicited in gender-specific ways. Group education issues, relational development, and attitude sets influence a woman’s learning 

as do demographic variables including ethnicity, race, age, and socioeconomic background. Health care providers

focusing on prevention need a better understanding of the impact of these issues so that they can bring information to their patients in a way that leads to the best health outcomes.

Although women’s health providers across the country are offering health education programs to women and

are achieving favorable outcomes, we do not have a clear scientific understanding of which programs work best 

for which women and why. Research on this issue would help NAWHP and others to improve health outcomes 

for women through primary and secondary prevention practices.

Alternative medicine. In 1993, David Eisenberg, et al. published results of a study that found that, “Roughly 

1 in 4 Americans who see their medical doctors for a serious health problem may be using unconventional therapy

in addition to conventional medicine...; 7 out of 10 such encounters take place without patients’ telling their medical doctors that they use unconventional therapy.” Further studies have shown that women use unconventional

therapy or alternative medicine more often than men.

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Professionals in women’s health currently provide their patients with alternatives to conventional medicine.

NAWHP members offer massage, therapeutic touch, yoga, acupuncture, natural hormones, and homeopathy. 

Data on NAWHP member surveys show that patients regularly request information about alternative health 

methods, yet, again we have no scientific data to document the effectiveness or the ineffectiveness of various 

alternative methods. 

Charles Ponte, Pharm.D., C.D.E., Professor of Clinical Pharmacy and Family Medicine

B.C.P.S., F.A.S.H.P., F.C.C.P. West Virginia University Schools of Pharmacy and Medicine

I shall discuss my vision of the role of the pharmacy profession and its relationship to women’s health issues.

The role of the pharmacist has changed from the earliest compounding of healing medicaments to the provision of

more sophisticated care. Since 1990, the pharmacy profession has come to embrace the notion of pharmaceutical

care. This paradigm shift espouses a new philosophy for the profession. The pharmacist has a shared and equal

responsibility with the physician and other health care providers to guarantee suitable outcomes and quality of 

life indicators stemming from a person’s drug therapy. Ongoing research efforts are underway to decide the 

clinical and economic benefits of pharmaceutical care to both patients and the overall health care system. 

Important gender differences do exist which may affect the quality of health care received by women. Sex 

discrepancies are found between diagnostic and treatment decisions, drug prescribing patterns, susceptibility 

to poor health care, communication with health care providers, recruitment for clinical trials and even drug 

action and metabolic fate. 

The pharmacy profession is beginning to recognize the unique health care needs of women. Both pharmaceutical care efforts and scientific inquiry are being directed toward solving gender-specific, drug-related problems.

Curricula in colleges/schools of pharmacy reflect an increased awareness and sensitivity to women’s health care

issues. Professional associations and publications are devoting more educational programming and editorial space 

for women’s health care topics. My own research has shown that many pharmacists are engaged in counseling

women about their unique health care concerns and that women tend to be proactive in requesting advice from 

the pharmacist. Notably, women want the pharmacist to be an active participant in their health care education

about prescription and non-prescription drugs (e.g., hormone replacement therapy, feminine hygiene products,

contraceptives, vitamins).

Despite these positive efforts, the pharmacy profession needs to continually seek a better understanding of 

the role of gender and its overall influence on the provision of pharmaceutical care. At the national level, there 

still remains a need to more thoroughly understand the attitudes of pharmacists regarding women’s health issues

and to discover the kinds of pharmaceutical care services rendered to women. These and other “pharmacogender”

research endeavors will better define the profession’s future initiatives aimed at women. Such initiatives could include
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focused disease state management strategies (e.g., diabetes mellitus), curricula revisions, outcomes development,

and public policy framing. Collective involvement by pharmacists (the most accessible health care provider) 

in the women’s health care arena could result in an improved health status for women and its attendant socioeconomic benefits.

Linda Ransom Self

I am the mother of 10-year-old, Tara. Tara is dependent on a shunt made of silicone to control hydrocephalus.

The current litigious climate in the United States endangers the supply of raw materials for her shunt and other

life-saving and life-enhancing implantable medical devices such as pacemakers, hip and knee joints, and cataract

lenses. With the shunt, Tara is an accomplished young lady who deserves the chance to live to become a productive woman. Without shunts and other medical devices, Tara and many others will face painful deaths. Although

Tara has had five shunt-related surgeries, we know that the day will come when she needs another replacement or

revision if for no other reason than growth. The medical technology to save her exists, but the availability is threatened. We cannot continue to allow lawsuits to dictate the medical options available to women today. This will

increasingly impact and overlay all areas of women’s health in the near future unless something is drastically changed.

Since women live longer lives, they can expect to need more devices, making this very much a woman’s issue.

Joan Y. Reede, M.D., M.P.H., M.S. Harvard Medical School

As assistant dean for Faculty Development and Diversity at Harvard Medical School, I wish to share with 

you the history of this department and how we have addressed the issue of minority underrepresentation in the

biomedical sciences. The Office for Faculty Development and Diversity was established in 1995 to:

• Provide leadership, guidance, and support for academic and professional career development, and

• Promote increased recruitment, retention, and advancement of underrepresented minorities and women.

Historically, African Americans, Mexican Americans, Puerto Ricans, and Native Americans have been chronically

underrepresented in the biomedical sciences. The rise in minority medical student enrollment in the late 1970s

should have resulted in a concomitant increase in the representation of minority physicians, scientists, faculty, 

and leaders in the 1980s and 1990s.

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Between 1971 and 1994, there was an increase in the number of minority medical faculty from 1,001 to 

2,813 — an increase from 3.4 to 3.9 percent when compared to total faculty. The Association of American Medical Colleges attributes part of this growth to the accreditation of three predominantly minority medical schools. 

In fact, six of the 125 medical schools in the United States account for approximately 27 percent of all underrepresented minority faculty. In essence little progress has been made.

If underrepresented minority students are to become future leaders in our academic medical centers research

institutions, industry and government, they must be informed of educational, training, and employment opportunities and must be encouraged to pursue positions where they can become change agents.

Harvard Medical School (HMS) has created a system of programs designed to address minority faculty 

underrepresentation. In May 1990, the Minority Faculty Development Program (MFDP) was established. This 

program became part of the Office for Faculty Development and Diversity in 1995. The four goals of MFDP 

were to: (1) increase the number of medical school minority faculty; (2) increase the number of minority professionals who enter graduate medical education programs at HMS-affiliated hospitals; (3) establish program 

models for the development of minority faculty, with an emphasis on mentoring; and (4) develop outreach 

precollege and college programs.

Reviewing national, regional, and local efforts to increase minority participation and advancement in the 

sciences revealed three recurring obstacles to achieving these goals. First, there has been poor communication of

information pertaining to prerequisites for entry and advancement, poor communication on available supports 

such as targeted programs, scholarships, research supplements, and fellowships and insufficient understanding on

how to get through the bureaucracy. The second obstacle has been the ongoing lack of continuity in advancing 

students, trainees and professionals from one stage to another along the career pipeline. Succinctly stated, in the

development and implementation of programs, “the right hand often does not know what the left hand is doing.”

Third, there is an absence of evaluative data on the effectiveness of strategies and outcomes achieved.

Having determined these obstacles, programs were designed that furnished information about training opportunities and funding resources; provided students exposure to academic health centers, research experiences, and

faculty role models; improved the preparedness of students, residents, and junior faculty to make informed career

decisions; and promoted the development of mentoring relationships and supported the building of student and professional networks that cross disciplines, departments, and institutions. A brief description of several programs follows.

Precollege. At the precollege level, MFDP implemented programs that include the development of science 

curricula used in middle and secondary classrooms; through the Teacher Institute, the training of science teachers 

in both laboratory techniques and the use of the case study method; and through Project Success, hands-on, 

mentored research experiences for high school students.
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College. Students completing the precollege program can continue in Project Success while in college. They 

can also be linked to research programs at HMS-affiliated hospitals, in private industry and at other academic and

research institutions. In addition, MFDP sponsors a health policy summer research program for college students

who attend Minority Access to Research (MARC)-funded historically black colleges and Hispanic-serving institutions.

Medical Student. Through the Visiting Clerkship Program (VCP), another MFDP project, more than 250 

underrepresented minority students from U.S. medical schools have participated in the HMS Exchange Clerkship

Program. Along with financial support, this program informs students about residency and fellowship training

opportunities and provides career guidance from senior faculty. VCP’s success is measured not merely by the number of student participants who become HMS residents, but by whether students become better informed about

existing academic training opportunities and the impact their current choices will have on future career options.

Biomedical Science Careers Project. In conjunction with the Massachusetts Medical Society and the New 

England Board of Higher Education, MFDP founded the Biomedical Science Careers Project (BSCP). BSCP is 

a not-for-profit organization that provides New England minority trainees, junior faculty, and students (from 

high school through graduate school) with mentors, career guidance, and comprehensive information on programs and opportunities. BSCP is supported by a collaboration of area professional societies, teaching hospitals,

biotechnology companies, community and 4-year colleges, universities, high schools, and private industry.

Since its inception, this organization has initiated several activities including the publishing of the New England

Resource Directory of Science Programs, producing a newsletter — In Touch with BSCP — distributed to more than

2,500 students, teachers, guidance counselors, administrators, and community organizations, as well as sponsoring

regional conferences that have brought together more than 1,500 minority students and professionals with senior

advisors and mentors.

Fellowship. During the implementation of the above programs, major changes continue to occur within the

areas of academic medicine, health care, public health and health policy. These changes include: movement toward

increased enrollment in managed care, increasing emphasis on quality and outcomes, persistent disparity in health

status among various ethnic and racial populations, shifting support for graduate medical education, and increased

competition for research dollars.

In this changing environment as policies are developed, priorities are set, and funding is allocated, it is imperative that minority physicians and scientists be included in the decisionmaking process. Failure to include minority

individuals, as leaders with recognized expertise and the power to make decisions, will result in solutions that are

exclusionary, shortsighted, and continue to be less than effective.

Recognizing the need to proactively prepare physicians to assume leadership roles in this era of change, 

MFDP, through a collaboration between Harvard Medical School, Harvard School of Public Health, and the 

Kennedy School of Government, has established The Commonwealth Fund/Harvard University Fellowship in 

Minority Health Policy. This is a 1-year, full-time, academic, degree-granting program designed to create physicianleaders, particularly minority physician-leaders, who will pursue careers in health policy, public health practice, 

and academia. A total of 25 fellowships will be awarded over a 5-year period.

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The Fellowship has five primary objectives:

1. To enhance the leadership skills of physicians, preparing them to identify, analyze, quantify, and develop

solutions to public health problems and offering them substantive knowledge in health policy, financial

and organizational management, communication, politics, economics, and ethics, while creating 

a network of physician-leaders capable of advancing successfully among the public, nonprofit 

and academic sectors;

2. To provide rigorous academic training, including both academic work leading to a master’s level 

degree in public health and advanced leadership training beyond it;

3. To develop physician-leaders who will, over time, improve the capacity of the health care system 

to address the health needs of minority and disadvantaged populations;

4. To enhance the health leadership training offerings at Harvard institutions; and 

5. To remedy the underrepresentation of minority physician-leaders who are well-trained academically 

and professionally in clinical medicine, public health, health policy, and health management, and 

who are prepared to pursue careers that bridge the academic and public service arenas.

Over the past 7 years, the Harvard Medical School Office for Faculty Development and Diversity and the 

Minority Faculty Development Program have made substantial strides in trying to increase the numbers of 

minority students pursuing biomedical careers, residents in academic training programs, and physicians preparing for leadership roles. In addition, individual counseling and career development programs have been 

provided for fellows and junior faculty. Next steps include increasing the availability of mentors and addressing 

issues of promotion and retention.

Karen C. Renick Board of Directors, DES Action USA

The Health Legacy for Women of the DES-exposed Population

The National Cancer Institute estimates that only 50 percent of the 10 million DES-exposed people are aware 

of their exposure today. This lack of awareness is hardly benign. It translates into a public health crisis which is 

both serious and complex. It means that millions of Americans were exposed to a toxic drug without knowing it.

Accordingly, this population has no idea that their health, and ultimately their lives, may be in jeopardy because 

of a dangerous drug administered decades ago. At present, they are not receiving the critical information they 

need regarding screening and followup medical care.
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Today the hazardous effects resulting from in utero exposure to DES are well known. For DES daughters, these

effects include clear cell adenocarcinoma of the vagina and cervix, structural malformations of reproductive organs

leading to infertility and pregnancy disasters, and effects on the immune and other bodily systems. Women who

took DES during pregnancy face an increased risk for breast cancer, and DES sons have an increased risk for 

reproductive tract abnormalities.

These health effects are compelling reasons for addressing the needs of the DES-exposed population. Furthermore, research on the effects of DES are far from conclusive and the serious health consequences faced by all 

DES-exposed women require further research to determine both long-term effects and appropriate treatment.

DES is an important model to consider as we face the question of the inclusion of pregnant women in clinical

drug trials. DES is also a well-known and significant example of a hormone disrupter. With today’s widening appreciation of the power of estrogens to affect our bodies, we need to follow through and learn as much as possible 

to understand the full implications of long-term, worldwide exposure to endocrine disrupting chemicals.

DES Action poses the following research questions: (1) Will there be a new peak of clear cell vaginal or cervical cancers as DES daughters reach menopause? (2) Will DES daughters, as we age, develop an increased rate 

of breast cancer as animal studies seem to suggest? (3) Should DES daughters be candidates for hormone replacement therapy during menopause? (4) What are the long-term effects of fertility drugs on a population already

exposed to synthetic estrogen in utero? (5) What are the effects of DES on the endocrine, skeletal, cardiovascular,

neurological, and immune systems? and (6) What are the risks for the third generation exposed to DES? 

Director, Research Area VI

Colonel Irene M. Rich U.S. Army Medical Research and Materiel Command

In the last few years, targeted Congressional biomedical research funding to the Department of Defense (DoD)

has resulted in significant advances in women’s health research. The DoD Breast Cancer Research Program (BCRP)

is the largest of these efforts. The program aggressively seeks to identify gaps in breast cancer research funding,

enhance previous accomplishments, and contribute to a comprehensive national effort that will benefit all citizens

through scientific innovation and technology transfer. The BCRP has funded research at 828 institutions in the 

U.S. and abroad with a variety of funding categories to support basic and clinical research projects, training grants,

and infrastructure enhancement awards. Programmatic goals include addressing the needs of minority, elderly, 

low-income, rural, and other underserved populations.

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The BCRP fosters partnerships, collaborations, and interdisciplinary studies at several levels. BCRP stakeholders include key scientists, national leaders, and consumers from government, academic, and consumer 

advocacy organizations. Two consumers are assigned to each scientific peer review panel. The Idea Award 

Philosophy was created to stimulate and reward speculative but promising and creative ideas. Internet Web 

sites, the Arden Knowledge Management System (AKMS), and multidisciplinary meetings are the primary 

research dissemination modalities.

FY 93/94 BCRP Research Achievements. To date, projects have resulted in the publication of 380 manuscripts. BCRP-funded research has been presented at more than 300 national and international meetings, and 

investigators currently hold 9 new patents or licensures. Several BCRP infrastructure projects are acquiring breast

cancer survival data and morbidity and mortality information, and are identifying women at high risk for the 

disease. Single- and multi-center clinical trials have been initiated to aid in the diagnosis/detection of breast 

cancer. Advances have been made in the detection of cellular abnormalities in breast cancer. Funded BCRP 

investigators have made progress in drug trials for therapy, treatment, and aftercare. Some examples of BCRPfunded projects on quality of life include pain management, benefits of counseling, access to care, and care following treatment; some results indicate the need to further address specific concerns and issues of ethnic groups.

Investigators funded by the BCRP have developed model systems that can characterize mechanisms involved in

the pathology of breast cancer, tumor progression, and metastasis. BCRP researchers have shown that increased

breast cancer risk is associated with high sunlight exposure, high residential solar radiation, and high dietary 

Vitamin D intake. Eleven new mutant strains have been developed and 10 new breast-related cell lines have 

been developed.

Emerging Breast Cancer Research Issues. Increased sensitivity to the spectrum of issues surrounding patient

care including psychosocial, sexual, quality of life, and cultural dimensions is needed on all fronts. Breast cancer

prevention must address genetics, environment, and lifestyle. Answers to questions of hormonal deprivation/

replacement and childbearing for the patient with breast cancer remain elusive. Improving access and utilization 

of health care services, especially to underserved populations, remains a major challenge. The explosion of diagnostic and treatment complexities demands improved education and information services, enabling each patient 

to have optimal resources for decisionmaking. Consideration of the ethical dilemmas posed with each new diagnostic and treatment advancement must become standard practice. The most important systems issues are

enhanced coordination among all agencies and researchers and the creation of additional national infrastructures to support technologies and rare specimens.

Other DoD Women’s Health Research Programs. The goal of the Defense Women’s Health Research Program 

is to combat health problems unique to military women, that are especially prevalent among military women, 

or that have a large impact on mission performance. Other programs include the DoD Osteoporosis Research 

Program and the DoD Ovarian Cancer Research Program.
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The DoD is a relatively new player in the women’s health research arena. The traditions of focused military

determination and operational capabilities and the infusion of creative science management to expediently and

responsibly fund the most urgently required research have enabled the DoD to become a catalyst for new insights,

technologies, and partnerships across the spectrum of women’s health research issues.

Peggy Roberts, M.D. Self

As a practicing primary-care physician for 20 years, I spend less time preventing injury, cancer, and chronic

disease and more time helping people manage symptoms and dysfunction from these conditions and overcoming

barriers to their care. I value opportunities to reinforce healthier lifestyles, safety, and stress reduction, and to

encourage health maintenance and well-person exams for screening and further education. I feel that knowledge 

of one’s state of health and of preventive measures, along with detection of possible disease and injury, can give

individuals choice in further evaluation and treatment options. However, much early detection does not represent 

prevention or even secondary prevention as claimed by some well-known health campaigns.

True primary prevention means limiting the incidence and extent of disease and disability in the first place 

and supporting our body’s own homeostatic mechanisms for maintaining health and healing. One way we can 

help prevent the increasing rates of many malignancies, reproductive disorders, and infertility, as well as some

chronic diseases in women, is to understand and respond to the growing evidence of the deleterious effects of 

toxic chemical and pollutants in the environment on our own health as well as on that of wildlife around us.

I wish to focus on a review of environmental components of women’s health and their effects during a 

woman’s life span. I strongly recommend that ORWH study the texts and include specific research recommendations from recent and upcoming reports on known, environmentally related women’s health conditions. 

In studies and by testing of mutagenicity in animals, natural as well as man-made chemicals and radiation have

been found to act directly and possibly indirectly as environmental triggers of cancer. Chlorinated hydrocarbons,

herbicides, and heavy metals can mimic estrogen in our bodies. These toxic chemicals can also have other endocrine-disrupting activity and genetic-damaging effects in susceptible individuals; they are lipophilic and accumulable in fat tissue throughout life. In utero exposures to these toxic chemicals can cause fetal loss, birth defects, and 

neurologic developmental deficiency or even delayed immunological effects. Skeletal and nervous systems can be

affected during times of growth, including in utero development. Asthma and autoimmune diseases are often more

active during pregnancy and may be susceptible to adverse effects of hormonally active environmental toxicants. 

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For women, occupational exposure to chemicals and chemical processes can adversely affect fertility, cause

pregnancy abnormalities, and increase risk of cancers. Obtaining more demographic information through ongoing

studies such as the Women’s Health Initiative and the Nurses’ Study may help show whether occupational or 

recreational exposures to environmental toxicants play a role with other risk factors.

There is certainly abundant evidence of adverse effects and risks for women from exposure to environmental

toxicants throughout their life spans, along with a need for more education and for continued research on ways to

diminish the impact from these exposures. As a public-health-minded primary-care physician, I feel it is prudent

and precautionary to advise a reduction of much environmental exposure to these toxicants for women, as well 

as for all individuals in families and communities and nations, in order to prevent known disease and disability.

• We can insist on our right to cleaner air and water and on our right to know what kinds and levels 

of toxins are produced and released into the environment in our home, work, and communities.

• We can require that chemicals be tested for endocrine-disrupting activities and possible indirect 

carcinogenicity and that containers be so labeled and the public informed.

• We can advocate for zero chlorine and dioxin discharge from all industry, including medical work 

incineration, and also for removal of chlorine from paper production.

• We cannot support the use or production of known toxic chemicals and drugs, including cigarettes, 

nor their exportation to other countries.

• We can avoid using pesticides and practice integrated pest management at home and in our communities.

• We can eat organic, pesticide-free foods, with more vegetables, grains, beans, and fruit, and less fatty animal 

and fish products, thus minimizing body fat and potential toxic chemical burden.

• We can support education and outreach for affordable and safe home, work, and community environments 

for all persons in our country and abroad.

• We can ensure access to good health care for all.

• We can reduce waste and encourage recycling, relying less on petrochemicals, and supporting development 

and use of alternative, biodegradable and non-toxic chemicals and materials.

• We can continue further study, education, and outreach on the effects of the environment on our health, 

as well as on global health, and move towards less deleterious and more harmonious ways of living on 

and with this earth.
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Gail Robin Seydel Action for Women’s Health

The links between women’s health and industrially produced environmental contaminants is an extremely 

serious concern that must be addressed in future research and in outreach and educational efforts in large and

small, urban and rural communities. Understanding the links between health and environment has been popularized by the women’s cancer movement in light of the fact that approximately 70 percent of women with breast 

cancer do not have the established medical risks and the breast cancer gene only accounts for about 5 percent of

women. Looking for answers to what can be called a plague on our nation’s women, that grassroots movement 

spotlighted the research and work of scientists and doctors, including Ana Soto, Mary Wolfe, Devra Lee Davis, 

Theo Coburn, and many others as it searched for answers.

More work must be done in this area if we are to prevent breast cancer as well as address a host of other

women’s health problems. With over 70,000 chemicals in our air, water, soil, food, household products, feminine

hygiene products, cosmetics, etc., that have yet to be tested for endocrine-disrupting effects, both individually 

and in combination, every woman is at risk from the toxic soup in which we live. The fact that organochlorines, 

as well as other chemicals, heavy metals and radioactive materials can cross placenta barriers and affect the first

environment all humanity experiences, our mother’s womb, makes this research of immediate importance to 

the well being of future generations.

Exposure to environmental contaminants has been shown to cause health problems, including all kinds of 

cancers, infertility, other reproductive disorders, endometriosis, birth defects, behavioral and learning disabilities,

diabetes, and other health problems in test animals with exposure levels within which those we women currently

experience. Most affected are poor women and women and communities of color. Here in New Mexico this is 

of great importance with Native American and Hispanic peoples being a large proportion of our population. 

A variety of research, regulatory, education, and outreach opportunities and suggestions to respond to 

and combat the above ills will be presented as part of my testimony. 

Cynthia M. Shewan, Ph.D. The American Physical Therapy Association

The American Physical Therapy Association appreciates the invitation to participate in the development 

of a research agenda for women’s health research in the coming decade. The Association believes that research 

is especially needed in the following areas:

Environmental. The workplace should be studied to identify and correct health hazards for women as well 

as men. In particular, research is needed to identify practical, effective ways to protect workers from job-related

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musculoskeletal risks, including repetitive stress syndrome. This research area is particularly important because

musculoskeletal disorders are the country’s most costly category of workplace injury and illness.

Recreational and Sports-related Injuries. As more women participate in recreational and organized sports 

activities, investigations into the prevention, causes, and treatment of musculoskeletal injuries, especially knee

injuries, are needed.

• Emphasize continuing research into the prevention of osteoporosis and hip fractures, including designing 

effective strategies to instill good exercise habits. 

• Study the influence of exercise and physical activity on balance activities, including the prevention of falls. 

• Conduct additional research on the benefits of exercise for the prevention of disease and disability.

Chronic Conditions

• Increased research is needed on chronic conditions and diseases, such as cancer, stroke, diabetes, and 

chronic pulmonary disease, that impact the quality of life of older women in the U.S. 

• Additional research is needed to improve urinary incontinence treatments, including behavioral techniques,

muscle exercises, and biofeedback. 

• Cardiovascular disease, especially in women over age 50 years, continues to have a major impact on women’s

health. Research on the etiology, prevention, and treatment of cardiovascular disease and cardiac rehabilitation

for women is needed. 

• Osteoarthritis has disabling effects on the musculoskeletal system. Research is needed to identify the most 

effective way to reduce musculoskeletal impairment and improve function. 

• Osteoporosis affects an estimated 20 million Americans and is most common in the elderly and in postmenopausal women. Additional research on the prevention and treatment of osteoporosis, including studies on 

the effectiveness of weight-bearing and weight-training exercise, is indicated. 

• Diabetes is associated with long-term complications that affect almost every major part of the body. Additional research is needed, including the prevention and treatment of foot ulcers, due to both neurologic 

and vascular complications.

The mission of ORWH should be expanded to monitor funding for women researchers and career 

opportunities, and to ensure equality and the elimination of career barriers for women. 
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Susan M. Shinagawa Self/Intercultural Cancer Council

Breast cancer incidence and mortality rates in Asian Pacific Islander (API) women are consistently reported 

to be among the lowest for all women in the United States. These low rates for API women compared to all other

ethnic groups have led to the belief among health care providers, public health policy makers, governmental agencies, and the general population that API women are not at risk for breast cancer. But these statistics are skewed.

They have perpetuated a dangerous myth and provided justification for an outcome all too familiar to API communities — once again, when health care dollars are allocated, we are left out of the equation.

Currently, reported breast cancer statistics for API women are skewed because API populations have (1) the

highest immigration rates at nearly 70 percent, (2) immigrating from their native countries with the overall lowest breast

cancer incidence and mortality rates in the world, and (3) have the lowest median age of all U.S. populations (risk

of breast cancer increases with age). As the current API population ages, acculturates, and increases due to fertility,

the reported incidence and mortality rates will begin to show a steady increase. Yet, the rapid growth of API populations fueled by immigration over the next 10 to 15 years will prevent the statistics from depicting an accurate picture

of breast cancer risk in APIs. And the trend to study cancer in API populations as an aggregate group only obscures

the reality of breast cancer risk, incidence, and mortality in our many diverse and divergent subpopulations.

In fact, while the ACS reported last year that U.S. cancer deaths are declining, cancer deaths have actually

increased at a faster rate among APIs than any other U.S. racial/ethnic population. Between 1980 and 1993, cancer death rates for APIs more than doubled (290 percent for males and 240 percent for females), representing 

the highest percentage increase in the U.S.

These inaccuracies are now reflected and will continue to be reflected in the lack of knowledge about actual

female cancer risks among API women, and the paucity of health care research, funding and programs targeted to

(breast) cancer outreach and education in API communities, which will continue to result in late stage diagnoses

with a disproportionately high mortality rate. The myth that API women are not at risk for breast cancer (1) promotes a false sense of health security among API women, (2) creates the illusion among health care providers and

policy makers that there is a lack of need for breast cancer education, screening, diagnoses, treatment and support

among API populations, and (3) validates the arguments that justify policies precluding the utilization of resources 

to provide for the overall spectrum of breast cancer in API populations.

In addition, the perception among health care providers and public health policy makers of APIs as the “model

health minority” (another well established myth in the American medical and political milieu — that APIs take care

of themselves and do not require preventive and first-line health services) only serves to exacerbate this situation,

resulting in a lack of culturally competent outreach and intervention for these diverse populations.

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Utilization of demographically based projections of API cancer research and incidence/mortality rates are 

critical and necessary tools in developing sound public health policies for U.S. API communities. In addition, the

immediate development and implementation of a multifaceted effort to educate API women on healthy lifestyle

interventions and early detection methods; the education of health care providers and public health policy makers

about actual breast (and other) cancer risks in API communities; and a culturally competent, community relevant,

and language appropriate U.S. health care system is imperative to preclude a virtual (breast) cancer epidemic in 

API communities over the coming decades. 

Susan Silverton, M.D., Ph.D. American Association of Dental Schools

Dental and oral diseases affect most older Americans; 99.5 percent of Americans 65 years and older have had

cavities and 40 percent of these elderly Americans have lost all of their teeth. Of those who are poor, a disproportionate number are also edentulous. In the edentulous elderly population, only 10 percent had a yearly dental visit.

In addition, those in poorer health or limited by disability have fewer regular oral health followup visits. By the

year 2000, it is estimated that $62.3 billion will be spent yearly on dental services. Yet, only 15 percent of those 

65 and older have dental insurance.

Gender-specific data on women shows that increasing age is accompanied by an increase in the edentulous

population. While women aged 45 to 54 have only a 12 percent prevalence of complete loss of teeth, 46 percent 

of women over 75 years of age have lost all their teeth. The loss of teeth does not signal an end to the need for 

oral health care. In fact, the health problems of edentulous patients demand continued care. The vast majority 

of nursing home residents are women. New nursing home regulations on oral health care have been in place for 

2 years, but oral health screening is not standardized and no provision is made for coverage of oral health care

costs unless the service required is an emergency or is covered by Medicare. 

Oral Health Diseases of Postmenopausal and Elderly Women. Oral conditions may undermine an elderly person’s

quality of life. Several of the most common oral health diseases occur more frequently in elderly women. These

include temporomandibular disease; trigeminal neuralgia; atypical facial pain; pemphigus; burning mouth; 

discoid lupus erythematosus; and oral cancer.

Oral Manifestations of Systemic Disease. Sometimes, oral symptoms are the prodrome of systemic disease. 

Some examples of systemic diseases that oral health care practitioners recognize and treat include anemias; 

multiple myeloma; Paget’s disease of bone; and diabetes mellitus.
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The Traditions of the Oral Health Practitioner Include Prevention and Screening. Oral health practitioners have a 

tradition of providing effective preventive health care. Eighty percent of general practitioners are trained to take 

a comprehensive medical and oral history, blood pressure and any other diagnostic tests which are required for 

risk assessment prior to the surgical treatments of health care. Preventive counseling highlights caries and periodontal care. Dental care practitioners also include information on smoking and tobacco cessation (oral cancer 

risk), and nutrition counseling. In older or more medically compromised populations, dentists are competent 

to take blood pressures and recommend a physician followup for hypertension control.

Oral Health in the Medical Curriculum. Although there is considerable overlap in the knowledge base of physicians and oral health practitioners, there are also barriers in the education and training of these practitioners 

that limit the integration of oral health care and general health care. However, these barriers are being challenged.

Ongoing surveys and reports of the medical and dental curriculums should lead to reevaluation of the gaps

between the training of health care and oral health care practitioners. One goal should include structuring the

respective curricula to provide linkages between the disciplines of medicine and dentistry. Curricula can be

designed to decrease the knowledge gaps and to lower barriers to the practice of integrated care. As far as 

practice integration is concerned, integrated medical and dental services are now beginning to be offered 

in some managed care settings. Working together on the same patients should help oral health and health 

care practitioners achieve better integration of oral health and health care for women.

Recommendations for Oral Health and General Health Care for Postmenopausal and Elderly Women. 

• Improve science transfer/education of the public; and

• Strengthen the linkages between oral health and general health. 

Committee on Women in Science and Engineering

Linda C. Skidmore, M.S. National Research Council

CWSE is the one unit of the NRC that focuses on the retention of female scientists, engineers, and technicians

(SETs) in science-based education and employment. This Committee has the broad mandate to increase the participation of women in the scientific and engineering (S&E) labor force. Despite women’s increasing participation in

the S&E work force during the past decade, the rate of increase of the participation by women of color (minority

women) in both post-secondary S&E education and science-related careers remains fairly constant.

• At the undergraduate level, according to NSF (1996), “underrepresented minorities — blacks, Hispanics, and

American Indians — are as likely to earn bachelor’s degrees in science and engineering as they are to earn bachelor’s degrees in other fields.” In 1993, the rates ranged from 7 percent for blacks, 5 percent for Hispanics, but

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only 0.5 percent for America Indians. However, the rates were even lower for undergraduate women of color:

of all S&E baccalaureate awardees, only 3.9 percent were black women, 2.5 percent were Hispanic women, 

and 0.3 percent were American Indian women.

• 1996 data available from NSF reveal that “minorities earned 17 percent of master’s degrees in science and engineering in 1993, compared with 13 percent in 1985;” however, no change was found for American Indians 

and the increase for both blacks and Hispanics was only 1 percentage point. At the same time, women were

35.8 percent of all S&E master’s degree holders in 1993. Women of color were almost lost among the “17 

percent” figure, for they comprised a smaller group of S&E master’s degree holders that year: 2.3 percent 

were black women, 1.5 percent were Hispanic women, and 0.2 percent were American Indian women.

• While the basic biomedical sciences, behavioral sciences, and nursing remain attractive to women, oral health

research and health services research have recruitment rates less than half of that for basic behavioral sciences.

At the same time, women comprise about one-third of the participants in NIH’s Medical Scientist Training 

Program (MSTP), which produces physician-scientists.

• Among S&E doctorates, the committee found significant underrepresentation of minorities (particularly 

minority women) in all other research areas, noting an “alarming shortage of researchers” of all racial ethnic

groups in oral health; in that field, participation by black women and men actually declined about 1 percentage point, to 2.6 percent, between 1986 and 1993. In fact, blacks and Hispanics were underrepresented 

in all five areas as well as among physician-scientists. Native Americans were particularly underrepresented

among the behavioral science research personnel. Representation by Asians typically reflected their percentage in the total U.S. population; however, the study found that they were underrepresented in the 

behavioral sciences but overrepresented in oral health research.

• Little difference is found in S&E employment: women are most likely to hold part-time research positions and

to be concentrated at the rank of assistant professor. For instance, in 1993, women comprised only 13 percent

of physician-scientists and less than 19 percent of oral health researchers. Among research faculty, women 

were most likely to be found in the lower ranks in the basic biomedical sciences and the behavioral sciences,

although they comprised about 40 percent and 55 percent, respectively, of researchers in those two areas.

As a result of the drastic underparticipation of women of color in the technological work force of the United

States, the National Research Council’s Committee on Women in Science and Engineering examined, during its

third national conference, both the quantitative information about their underparticipation and qualitative data 

that reflected the experiences common to many minority women interested in pursuing science-based careers.

Information presented here is drawn from the transcripts of that conference, “Diversity in Science: Perspectives 

on the Retention of Minority Women in Science, Engineering, and Health-Care Professions.”
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Anne Stansell United Silicone Survivors of the World

Contemporary health care services must work to bridge the gap between the legitimate illnesses suffered by

women with silicone breast implants and the manufacturers who say, “nothing’s wrong.” Manufacturers of silicone

breast implants spend millions of dollars on media advertisement, stilted research, and grants to medical schools.

The results are misled consumers, erroneous findings, and large profits!

The truth is found in the recipients of silicone breast implants: their failing health, their frustrated attempts to

achieve credibility, and the truth is found in real evidence. There is a need for support and communication among

the medical practitioners who can work free of excessive pressure and beyond the biases of previous research that

was funded and influenced by silicone breast implant manufacturers, such as the Harvard and May studies.

We want to share the over 1,300 peer reviewed, legitimate medical research articles available, one of which 

is by Robert Garry, M.D., immunologist and microbiologist and author of more than 200 articles on autoimmune

diseases. The challenge to the medical researcher: identify and name “like-syndrome” diseases which mimic 

classic diseases.

We must focus on the women and question the practice and motives of the manufacturers. Silicone disease 

is showing up in the second generation: the children of women with breast implants. Silicone is not biologically

nor chemically inert. Silicone breast implants are not lifesaving devices but life-shortening devices and banning 

all silicone devices is medical blackmail!

Leah Stiemel, M.D. New Mexico PreNatal Care Network

Prenatal care is one of the best examples of preventive care and represents the best investment of the health

care dollar. Prenatal care offers the best hope for improved pregnancy outcomes and thus represents one of the

most important components of obstetrical care. Women who do not receive early and continuous prenatal care

have three times the rate of low birth weight babies. Several preventable factors increase the risk of delivering a 

low-birthweight baby, including lack of prenatal care, maternal smoking, use of alcohol and drugs, pregnancy

before the age of 18, and lower socioeconomic and educational levels. Low birth weight is a primary predictor 

of costs: as birth weight falls, costs increase. An estimated more than $6 in neonatal intensive care costs could 

be saved for every $1 spent on prenatal care.

New Mexico continues to rank next to last in the nation for the percentage of women who receive the recommended level of prenatal care. In 1995, only 52.6 percent of pregnant women in our state received adequate 

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prenatal care. New Mexico still must make considerable improvements to reach the Healthy People 2000 goal 

of 90 percent of pregnant women receiving prenatal case in the first trimester of pregnancy.

There were 26,914 births in New Mexico in 1995. Of these births, 11.6 percent were born to women who

received late (third trimester) or no prenatal care compared to a national rate of 6 percent. Ethnic and racial differences exist when it comes to receiving adequate prenatal care in our state. In 1995, 61 percent of Anglo women

who gave birth received adequate prenatal care, while only 48 percent of Hispanic women received adequate 

prenatal care, and 40 percent of Native American women received adequate prenatal care.

In addition, the number of babies born to teen mothers New Mexico in 1995 was 18 percent; New Mexico

ranks 49 in the U.S. for teen birth rate (ages 15 to 17). Of these teen mothers, only 35 percent received adequate

prenatal care.

Why such dismal figures for New Mexico? Barriers to accessing adequate prenatal care are similar to access to

health care for anyone in New Mexico. In a largely rural state, there simply are not enough health care providers;

30 of the 33 counties are designated health care provider shortage areas. Rural women struggle with traveling long

distances for health care, and lack public transportation to get to appointments. New Mexico is culturally diverse,

so language and cultural barriers affect access to health care. Finally, a high level of poverty and lack of health care

insurance influence access to health care.

New Mexico has established two programs to improve health care access for women: the County Maternal

Child Health Program and the Community Health Worker model. The Maternal Child Health Plan Act was passed

by the New Mexico Legislature in 1991 to encourage the assessment and prioritization of maternal child health

needs and the formation of a maternal child health council at the county level. The Community Health Worker

Model is appropriate for New Mexico because it utilizes local resources to take basic education and health services to

the client in their home.

New Mexico sits in a vulnerable position with regard to health care for pregnant women, putting its women 

and future children at a real disadvantage for a healthy birth, and potentially costing New Mexico millions of 

dollars. Efforts must be increased at all levels, state, county, and local, to change our states’ poor ranking in 

this area. Prenatal care provided in a timely, continuous and regular manner, assists the woman in monitoring 

the progress of her pregnancy, provides her with essential health information to make sound decisions for herself

and her baby, and reduces her risk of having a low-birthweight baby. Improved prenatal care is important for 

New Mexico’s future.
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Cecilia Téllez Self

Not only are lesbians subject to the same barriers to health care as other women, but they are also subject to

barriers that are unique to their sexual orientation. Anti-gay bias within the medical community hinders the ability 

of lesbians to obtain comprehensive, quality health care. Examples of negative experiences include heterosexual

assumptions and bias during the medical interview; perceived health care provider discomfort in treating lesbian

patients; homophobic comments; repulsion; ignorance; and inferior care such as rudeness, intimidation, a rough

physical exam, and hostility toward the lesbian patient, her partner, and/or her children. Many lesbians conceal

their sexual orientation out of fear of disapproval, hostility, suboptimal treatment, or breach of confidentiality

resulting in losing her job, home, educational opportunities, insurance, or custody of her children.

Our study is the first large study done on physician attitudes since 1982. We found substantially less homophobia among physicians than previously reported. We found that the most homophobic specialties were, in

ranked order, general practice, orthopaedics, surgery, and pathology/radiology as a group. The four most homophilic specialties were psychiatry, pediatrics, emergency medicine, and family practice. We found that gender; 

specialty; urban versus rural practice; and association with lesbian and gay relatives, friends, colleagues, and

patients were associated with physician attitudes. Ethnicity was not associated with attitudes toward homosexuality. Physician homophobia was separate from issues of fear of AIDS. Although anti-gay bias among 

physicians is decreasing, it persists as a threat to the quality of patient care to the lesbian population.

Health Concerns. Lesbians have the same gynecological and non-gynecological health concerns as other 

women; however, lesbians also have unique health concerns. Although the risk for sexually transmitted diseases 

is lower for lesbians, those who have or have had sexual encounters with men are at risk for herpes viruses and

human papillomavirus, and can transmit these infections to their female sexual partners. Most lesbians with HIV

infection acquired it from injecting drug use or from having sexual relations with men. It is assumed that transmission of HIV between lesbians is rare; however, few or no studies document the rate of female-to-female transmission.

Lesbians are less likely to have an annual gynecological exam than other women. They are probably at higher

risk for breast cancer, ovarian cancer, and endometrial cancer than other women because they are more likely to 

be nulliparous. Lesbians who have never had vaginal intercourse with a man have a lower risk for cervical cancer

than women who have or have had male sexual partners.

Sexually active lesbians are just as likely as other sexually active women to have traumatic penetration from

digital, manual, sex toy, or penile penetration of the vagina or anus or from sadomasochistic activity. They also 

can have the same sexual dysfunctional problems that other women have.

Lesbian Families. A lesbian’s family may consist of her partner, members of her family of origin, children,

friends, or any number of diverse combinations. The partners of lesbians may be left out of family events or 

health care decisions made by lesbians’ families of origins. 

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Having children from a known donor either through insemination or heterosexual intercourse can potentially

set up a lesbian mother for custody battles. In addition, many clinics continue to refuse insemination services to

lesbians. Having children from any donors not screened for HIV puts the lesbian mother and her offspring at risk

for HIV infection. Many states and adoption agencies do not permit known lesbians to adopt children, making 

it a limited alternative for having children.

Pregnant lesbians may not have support from their families of origin. Role models and support systems 

are lacking for nonbiological lesbian parents. If the nonbiological lesbian parent is even allowed in the delivery 

room, she and the biological mother may not be allowed to have the same level of intimacy as heterosexual 

partners in labor.

Mental Health and Psychosocial Issues. Lesbians do not have any more mental illness than other women, although

they do have unique concerns related to their sexual orientation. They risk being rejected by their families of origin, friends, co-workers, and society at large. They risk losing their jobs, their homes, their custody rights of their

children because of their sexual orientation. They are at risk for hate crimes, verbal abuse, physical assault, sexual

assault, and murder. Coming out can even be stressful enough to lead to depression, self-harmful activities, and/or

suicide. No research supports the suggestion that psychosocial development of children with lesbian parents is

compromised compared to those who are not raised by lesbian parents.

My recommendations may be considered quite ambitious, but I hope that some, if not all, of them will be 

put into effect.

• Develop curricula, in conjunction with lesbian health experts and activists, on appropriate and sensitive 

bedside manner with lesbians, lesbian sexuality, and on health, family, and psychosocial concerns unique 

to lesbians for medical, nursing, and other health care schools to incorporate into their programs.

• Develop continuing education and re-certification curricula, in conjunction with lesbian health experts 

and activists, on appropriate and sensitive bedside manner with lesbians, lesbian sexuality and on updates 

in lesbian health for physicians, nurses, and other health care providers.

• Develop a quarterly newsletter to notify all health care providers of changes and updates in lesbian health.

• Develop a widespread campaign (to include patient literature; newspaper, magazine, radio, and television

announcements; and health fairs and lesbian events), in conjunction with lesbian health experts and activists, 

for lesbians of all ethnicities and languages, ages, and educational and economic backgrounds on what they

should expect from health care providers and on their rights as patients.

• Develop a widespread campaign (to include patient literature; newspaper, magazine, radio, and television

announcements; and health fairs and lesbian events), in conjunction with lesbian-health experts and activists, 

for lesbians of all ethnicities and languages, ages, and educational and economic backgrounds on the importance of routine and preventive gynecological and non-gynecological health care, and to dispel myths that 

lesbians have about their health risks and lack of health risks.
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• Develop outreach strategies on how to inform and update all lesbians on health, family, and psychosocial 

concerns unique to lesbians.

• Develop patient education materials to inform lesbians of all ethnicities and languages, ages, and educational

and economic backgrounds on lesbian sexuality, and on health, family, and psychosocial concerns unique to

lesbians and not unique to lesbians.

• Develop workshops on how health care providers can encourage lesbians of all ethnicities and languages, 

ages, and educational and economic backgrounds to access health care.

• Develop Lamaze, childbearing, and child raising classes for lesbians of all ethnicities and languages, ages, 

and educational and economic backgrounds.

• Develop workshops for domestic violence and sexual assault workers to better serve their lesbian clients.

Associates of Women’s Health

Patricia King-Urbanski, R.N., M.S.N., C.C.E., L.C.S. Obstetric and Neonatal Nurses

The Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN), has great interest in women’s

health research. AWHONN is an organization of 22,000 nurses whose primary practice is committed to the care 

of women across their life span and newborns. Our central purpose is to promote excellence in nursing practice,

education and research in women’s health, obstetric and neonatal health care, so as to improve the health and

health care of women and newborns. Our program of education, research, practice, and advocacy for the health

and health care of women and newborns based in the principles of health promotion, health maintenance, and

health restoration serve as testimony to this mission and purpose. 

We support and conduct research endeavors that strengthen the scientific basis of nursing practice. We believe

that research which seeks to improve the health of women across their life span, such as postmenopausal health

and reproduction is vital, as is research which seeks to improve the health of childbearing women and their infants. 

Today, many women are single heads of households, care for children and extended family members, and 

hold one or more jobs outside the home. Research in women’s health does not provide information about how 

the health of women in today’s society can be optimized. In addition, as has been widely documented, women 

have been represented inadequately in clinical trials. 

Natural menopause is a normal event in the lives of most women when they are about 50 years old. With 

a life expectancy of 82, women live one-third of their adult lives after menopause. Yet little research has been 

conducted on natural menopause and on the health problems of postmenopausal women.

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Heart diseases are the leading cause of death in women ages 55 and older. Until recently, however, women

have been under represented in studies of coronary heart disease. Among women who have cancer, breast cancer 

is the leading cause of death among women aged 35 to 54. Research studies on breast cancer dealing with 

epidemiology, early detection, treatment, psychosocial, and behavioral concerns is essential.

Childbirth is a significant experience for any family. Childbirth generally represents a positive experience; 

however, recent findings have demonstrated that more women die due to childbirth than has been previously

reported. Research must be aimed at improving the safety of the childbearing women. In relation to this, four 

out of ten American girls under the age of 20 get pregnant every year. Prevention of teen pregnancy is another 

crucial area in need of further research.

Societal issues such as violence against women and substance abuse are areas that need to be explored to 

determine effective support and treatment for women. For example, little is known about why some women 

leave their abusers and others do not. Women have been treated for substance abuse similarly to men. However,

research has shown that the effect of substance abuse is different in men and women. Comprehensive investigations are needed to develop effective treatment of women who abuse drugs and alcohol.

In view of these facts, AWHONN supports

• research that focuses on health promotion and maintenance, as well as disease prevention, throughout 

women’s life span;

• adequate representation of women in future studies of health problems, such as coronary heart disease;

• research on health problems that primarily affect women, such as breast cancer and osteoporosis; and

• research on diseases with social origins, such as substance abuse, teen pregnancy prevention and violence, 

as well as diseases of biologic etiology.

Sandra Welner, M.D. Self

There are over 27 million women with disabilities and chronic conditions in this country. These women are 

of all ages, races, and ethnic backgrounds. Disability does not discriminate. As America ages, all of us may confront a time in our lives where we may experience a decline in our independent functioning. Thus, as we chart 

new courses for improvements in health care delivery for women with disabilities and chronic conditions, these

improvements may affect many of us personally at some point in our lives. What are these gaps that I am speaking

of? Certainly you might say there are a lot of advances in health care research, health care policy, and all of these

changes and improvements most certainly should be improving health care for women with disabilities and chronic
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conditions by extension. Unfortunately, this does not happen automatically. Although all women have the same

chromosomal compliments, their health care needs may be vastly different from each other and from women in 

the “mainstream society.” I would like to turn your attention to key areas that I feel deserve our attention as we

chart new courses for improving health care for all women.

We may take it for granted that medical care, if available, can be obtained. Unfortunately, for women with 

disabilities and chronic conditions accessibility issues may prevent such medical care from being received. Structural barriers may limit access to facilities where medical care is administered although architectural barriers are

improving, not all private doctor’s offices and some older facilities may not have made the appropriate structural

modifications to allow easy entry for a woman with a disability or chronic condition. These women may be wheelchair users, ambulatory with canes or crutches, or suffer from a debilitating disorder that causes excessive fatigue,

making stairs and high curbs a daunting obstacle. Other aspects of physical accessibility should not be overlooked.

Some medical offices are not large enough to accommodate a woman in a wheelchair. Examination rooms may 

not be large enough to accommodate a patient in a wheelchair, an exam table and other exam room equipment 

permitting the patient and any assistant to have adequate space to get the medical care she requires. Bathrooms 

in order to be truly accessible must consist of more than a small closet-sized room with a toilet and handrail.

Guidelines for true accessibility in structural design are available but may not always be followed. 

Frequently suitable equipment is also not available. It is somewhat humiliating to have a woman have to go to

a loading dock to be weighed if she is in a wheelchair. Platform scales for wheelchairs are available, however, very

few centers caring for women have these on site. Examination tables that lower to wheelchair height are available

for purchase with special design tailored to the diversified needs of women with chronic conditions and disabilities.

However, these tables are often not found in many centers providing health care to women necessitating extra personnel to lift the patient on and off the examination table. This transferring has resulted in patient’s being dropped

and suffering further injuries. It is also somewhat humiliating for extra people to hold a woman’s legs apart while

the health care professional is performing a pelvic examination. Unfortunately, equipment that would eliminate

these dangerous and unpleasant experiences is frequently not purchased.

It is not surprising that if a woman cannot find accessible transportation to go to her medical appointments,

she will not receive medical care. This seems to be such an obvious barrier but in many locations reasonably priced

accessible transportation is unavailable. Some forms of insurance cover transportation to medical appointments,

and some do not. There are models in isolated areas across the country for low-cost accessible transportation. 

However, these programs have not been universally implemented in all locations.

Insurance coverage for necessary medical care may be quite limited for many women with disabilities and

chronic conditions, many of whom are not in the work force or are single parents, or may have low paying jobs.

There is a real disincentive for a woman with a chronic condition to be employed at a job which does not have

health benefits but has an earning level that would make her ineligible to receive publicly funded medical support.

Even when insurance coverage is available, the specialized types of care required by women with complex medical

conditions may not always be covered by the woman’s health plan. The specialists and facilities that are expert in

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her unique condition are often not among the participating facilities at which she is allowed to receive her care. The

false economy of having insurance cover sub-optimal care leading to serious secondary and avoidable complications

is obvious to women with disabilities and chronic conditions, but seems to be unrecognized by most health plans. 

In order to provide appropriate medical care, the guidelines for what appropriate medical care is need to be

determined. Because there has been so little attention focused on research into medical care for women with disabilities and chronic conditions, such guidelines and standards are very poorly developed. The gaps are many from

basic medical needs to reproductive health care, to issues surrounding the aging process. To complicate these issues

different disabilities affect a woman’s health in different ways, so generalizations on what would be applicable to 

all women cannot possibly apply. Each major disability group requires specific research questions to be asked and

answered. In order to map out guidelines for appropriate medical treatment and standards of care, this research

must be done. Otherwise it would be clearly impossible for necessary treatment to be ascertained as necessary, 

or alternatives explored. Some basic concepts pertain to health of women with disabilities and chronic conditions are known but are not being taught to health professionals in any comprehensive fashion, either during 

their training or in medical conferences and publications.

Twenty-seven million women, that is a large number of women. These women are becoming more empowered

because of the backing of federal legislation through the American’s with Disabilities Act, Human Rights Acts, and

other legislation. These are positive steps. However, these advances do not eliminate the gaps in medical care and

medical knowledge that restrict women from receiving appropriate and adequate comprehensive care. In these

women, more than in other populations, psychosocial factors may have a significant influence on compounding

existing limitations. These limitations could also be improved or eliminated with the acknowledgment of the

importance of assistive services to maximize independent functioning and productivity. This goal is a fairly universal

one and most women would prefer to be contributing members of society but may need some assistance in doing

so. If there is no medical coverage for such assistance, lack of knowledge on appropriate medical treatment, lack 

of awareness among medical professionals, and economic barriers for self determination women with chronic medical conditions, although desiring to continue to be healthy and productive, may be prevented from doing so.

Joanne M. Williams, R.N.C., C.N.P. OB/GYN Certified Nurse Practitioner

Lack of Knowledge Regarding Hormone Levels and Effects on Aging and Disease

It is a known fact that as we age our hormone levels drop, the aging process accelerates and degenerative 

diseases become more prevalent; i.e., decrease in mental function, decrease in muscle mass, coronary vascular 

disease, cancer (breast), osteoporosis, diabetes, etc. There is a lack of long term studies regarding the relationship

between these processes and all natural hormones, specifically the “super hormones,” i.e., DHEA, natural estrogens
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(estradiol, estrone, estriol), human growth hormone, melatonin, natural progesterone, pregnenolone, testosterone

and thyroid hormone. Because most studies are funded by pharmaceutical companies, they are conducted using

synthetic hormones. This is an opportunity for NIH to support research that includes natural hormones. 

More and more women are wanting natural solutions that produce improved quality of life as they age. Additionally, they are interested in the whole body (holistic) approach, which for many includes natural hormones. 

It is imperative that we develop a better understanding of these natural hormones and how they impact women’s 

health over their life span.

Caroline J. Yu, M.P.A. National Asian Women’s Health Organization

I wish to inform you about the most recent efforts of the National Asian Women’s Health Organization (NAWHO)

to expand the public knowledge about the reproductive and sexual health of Asian American women. NAWHO is the

only national agency of its kind that is solely dedicated to improving the health status of Asian women and girls.

NAWHO’s mission is to empower Asian women and girls through a framework that reflects commonalties and 

differences within Asian American communities, and ensure equal and adequate access to health care and life

advancement opportunities.

In the area of research, NAWHO’s goal is to close the major gaps in baseline health information, including gender and ethnic specific documentation, and address the need for reliable and timely data for policies and programs

on Asian American women’s health. In particular, NAWHO has focused on reproductive and sexual health needs

and concerns. NAWHO has found that overall Asian women’s sense of risk regarding reproductive and sexual

health is downplayed. Many Asian women only seek medical attention when the pain or symptoms of infection

became unbearable or interfered with daily functioning. 

To further examine these issues, NAWHO conducted a survey of 674 Asian American women in California, 

a study that has been documented in NAWHO’s 1997 publication, Expanding Options. The survey sought to 

analyze the knowledge of, attitudes towards, and use of reproductive health technologies by Asian American

women between the ages of 18 and 35 in six California counties with significant Asian populations.

The survey indicates clearly that Asian American women are sexually active and thus face a number of decisions regarding their sexual and reproductive behavior. In brief, the survey found that nearly half of the women

surveyed (49.8 percent) had not visited a health care provider within the last year for reproductive or sexual health

needs, compared to 3 percent of women in a nationwide Kaiser Family Foundation study. In addition, one fourth 

of these women have never received reproductive health care in their entire lives. Also, Asian American women 

are not adequately protecting themselves against pregnancy and sexually transmitted diseases, with 61 percent 

stating that they did not always use contraceptive methods.

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Based on the survey results, NAWHO makes several recommendations to health educators and providers,

women’s health advocates and activists, and policy makers in the areas of information, services, research, and 

policy, including the need to make no assumptions about Asian American woman’s knowledge and understanding of contraceptive methods or reproductive health in general. These recommendations are detailed in 

Expanding Options, which may be obtained by calling the NAWHO office at (415) 989-9747.

National Women’s Health Network

Diana Zuckerman, Ph.D. Institute for Women’s Policy Research

The National Women’s Health Network focuses on the need for women to make informed decisions about 

their health care. We are concerned about a wide array of health issues, but, reflecting the interests of women

across the country, breast cancer has been a particular concern. We believe that NIH would do a great public 

service by focusing greater attention on the unnecessary use of mastectomies in situations where the woman 

has no evidence of breast cancer, has no evidence of invasive breast cancer, or has a breast cancer that most 

experts believe does not require a mastectomy.

The history of breast cancer treatment in this country is a history with surgery as its central focus. Thousands 

of women were subjected to radical mastectomies before it was determined that less radical breast removal was as

effective in saving women’s lives, and even then, the practice of medicine changed slowly. Mastectomies were also

recommended for thousands of women with “fibrocystic breast disease” before research indicated that this was

unnecessary. Similarly, when NIH-funded research and an NIH consensus conference indicated that lumpectomies

were as effective with Stage I and Stage II breast cancers as mastectomies in saving women’s lives, there was still a 

lag before medical practice reflected those findings. In some parts of the country, it appears that women are still

being encouraged to undergo mastectomies in situations where virtually all experts would argue that they are

unnecessary. NIH has played an important role in informing doctors and the public about appropriate medical

treatment for cancer, and we believe that it is time for NIH to become more actively involved in some of the 

newer controversies regarding mastectomies.

Breast-conserving Surgeries. Several studies have shown that in certain parts of the country and at more 

sophisticated medical facilities, women with Stage I or Stage II breast cancer are more likely to undergo breastconserving surgeries rather than mastectomies. These regional variations were first noted in research published 

in the early 1990s. Although the rates of mastectomy as a percentage of breast surgeries has decreased in all 

regions of the country since then, the regional differences have been maintained. There are several possible 

explanations for these differences: the advice given by physicians, the attitudes of patients, and such practical 

factors as the difficulty of traveling long distances for repeated radiation treatment in some parts of the country.

Despite the NIH consensus conference in 1990, there is clear evidence that many patients are not receiving 

the information they need to make the choices that are best for them.
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Breast Cancer Genes and Preventive Mastectomy. Perhaps the most controversial issue is the use of mastectomy 

to prevent breast cancer in women whose family history of breast cancer has convinced them that mastectomy is 

the best strategy to save their lives. Certainly, women have the right to make this choice, but we are concerned 

that the choice is being made on the basis of very preliminary estimates of the likelihood of breast cancer associated

with the breast cancer genes (BRCA1 and BRCA2); these estimates could prove to be quite inaccurate. We turn to

NIH to do more to inform physicians and potential patients about these issues, such as holding a consensus conference, and supporting desperately needed research and public education efforts.

Ductal Carcinoma in Situ of the Breast. The diagnosis of ductal carcinoma in situ (DCIS) has been increasing 

in recent years, but the diagnosis remains poorly understood. Many women report that their doctors advised them 

to have a mastectomy “to be safe” even though there was no sign that the cancer would spread. Other physicians

tell their patients that DCIS is a precancerous condition or a very early form of cancer which can best be treated

with a lumpectomy, with or without radiation treatment. Differences in suggested treatment choices may be based on

differences in diagnostic findings, but it appears that differences in physicians’ attitudes and knowledge also greatly

influence the advice a patient is given. We believe that NIH can do more to study the extent to which mastectomies

may be unnecessarily performed for DCIS, and to inform the public and the medical community about the options

that are most appropriate under various circumstances.

Lobular Carcinoma in Situ of the Breast. The diagnosis of lobular carcinoma in situ (LCIS) of the breast is less

common, but the suggested treatment also varies from “watchful waiting” to double mastectomies. Since LCIS is

not a strong predictor of invasive breast cancer, we strongly believe that women should be fully informed before

making a irreversible decision to have a mastectomy. Again, we turn to NIH to do more to support research 

and inform the medical community and the public through a consensus conference or other means.

In conclusion, we are concerned that women patients who are at risk for breast cancer, have been diagnosed

with DCIS or LCIS, or Stage I or Stage II breast cancer do not always receive the most accurate, up-to-date information about their treatment options. Although NIH’s major focus is on basic research, NIH has played an important

role in improving medical treatment through a wide range of research projects, and through various public education strategies. These efforts are essential in helping to make more accurate, understandable information 

available to patients and consumers.

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Marjorie J. Albohm, M.S., A.T.C.

National Athletic Trainers Association

Amy Allina

Reproductive Health Technologies Project

Linda Burnes Bolton, Dr.P.H., R.N., F.A.A.N.

National Black Nurses Association

Lori A. Boyajian, D.O.

University of Health Sciences

College of Osteopathic Medicine

Joel O. Brende, M.D. 

Mercer University School of Medicine

Evelyn J. Bromet, Ph.D.

Sjögren’s Syndrome Foundation, Inc.

Sandra Brooks, M.D.

Society of Gynecologic Oncologists

Ross C. Brownson, Ph.D. 

Prevention Research Center

Saint Louis University School of Public Health

Alan P. Brownstein

American Liver Foundation

Jacquelyn C. Campbell, Ph.D., R.N., F.A.A.N.

The Johns Hopkins University School of Nursing

Molly S. Chatterjee, M.D.

Meharry Medical College

Bente E. Cooney, M.S.W.

National Osteoporosis Foundation

Zara Cooper, B.S.

Self

Brenda Crabbs

Arthritis Foundation

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Frances Cuomo, M.D.

American Shoulder and Elbow Surgeons

Leilani Doty, Ph.D.

Community Partners and 

University of Florida Health Science Center

Carolyn M. Dresler, M.D.

American College of Chest Physicians

Laura Flawn, M.D.

Scoliosis Research Society

Janet Heald Forlini, J.D.

The Center to Improve Care of the Dying

Julie Fleming Graham, M.Ed.

Self

Phyllis Greenberger, M.S.W.

Society for the Advancement of Women’s 

Health Research

Letha Y. Griffin, M.D.

American Orthopaedic Society for Sports Medicine

Andrew A. Guccione, Ph.D., P.T.

American Physical Therapy Association

Betty B. Hambleton

Health Resources and Services Administration

Jo A. Hannafin, M.D., Ph.D.

Orthopaedic Research Society

Betty Lee Hawks, M.A.

Office of Minority Health

U.S. Department of Health and Human Services

Susan Hendrix, D.O.

Wayne State University

Mary Hepburn, B.S.

Self

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NOVEMBER 17, 1997
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Nicolette Horbach, M.D.

American Urogynecologic Society

Mary Lloyd Ireland, M.D.

Ruth Jackson Orthopaedic Society

Anne Kasper, Ph.D.

Boston Women’s Health Collective

Marlene Keeling

Chemically Associated Neurological Disorders

Gwendolyn Puryear Keita, Ph.D.

American Psychological Association

Ann Kolker

Ovarian Cancer National Alliance

Virginia T. Ladd, R.T.

American Autoimmune Related Diseases Association

Mary Lamielle

National Center for Environmental Health Strategies

Marian C. Limacher, M.D.

American College of Cardiology

Lisa Lindahl

Epilepsy Foundation of America

Randall McCoy

CareTrends Health Education and Research Institute

Nancy K. Mello, Ph.D.

McLean Hospital

Virginia Miller, Ph.D.

Mayo Foundation

Ann Mulligan

DES Cancer Network

Mary Lynn Newport, M.D.

American Society for Surgery of the Hand

Gloria Nichols, Ph.D.

Catherine A. White, Ph.D.

The University of Georgia

Nancy J. Norton, B.S.

International Foundation for Functional 

Gastrointestinal Disorders

Nancy L. Parsley, D.P.M.

American Podiatric Medical Association

Kenneth A. Perkins, Ph.D.

Self

Jann Primus, Ph.D.

Spelman College

Bette A. Rank

Thomas M. Bruckman

American Foundation for Urologic Disease

Vicki Ratner, M.D.

Interstitial Cystitis Association

Sally A. Rudicel, M.D.

American Orthopaedic Foot and Ankle Society

Rosalie Sagraves, Pharm.D., F.C.C.P.

American Pharmaceutical Association

Charlotte (Barney) Sanborne, Ph.D.

Texas Women’s University

Barbara Seaman

National Women’s Health Network

Diane K. Seay

National Association for the Advancement 

of Women in Science

Wesley Segawa

Emory University School of Nursing

Amanda Sherman

DES Action USA

Eleanor G. Shore, M.D., M.P.H.

Harvard Medical School

Amanda Spitler

American College of Rheumatology

Donna E. Stewart, M.D., D.Psych.

Toronto Hospital

Deborah Studen-Pavlovich, D.M.D.

American Association of Dental Schools

Laura Lowe Tosi, M.D.

American Academy of Orthopaedic Surgeons

Charlene Waldman

Paget Foundation

Joanne A.P. Wilson, M.D., F.A.C.P.

American Gastroenterological Association

Ruth York, R.N., Ph.D., F.A.A.N.

Association of Women’s Health

Obstetric and Neonatal Nurses
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Marjorie J. Albohm, M.S., A.T.C. National Athletic Trainers Association

Physically active females are a rapidly expanding population. The positive benefits of physical activity are 

well documented. These benefits have been, and continue to be, realized by large numbers of females of all 

ages, throughout their life span. 

Physical activity, by its inherent nature, increases exposure to injury. Injury can be a limiting factor in 

relation to exercise compliance and a major source of health care dollar expenditures. 

To prevent activity-related injuries, minimize their effect, and ensure a safe participation environment for 

physically active females, a nationwide injury surveillance system designed to document, track, and monitor the

injury/illness patterns of this population, must be established immediately. Only when injury/illness patterns are

identified can appropriate preventative interventions be developed and implemented.

Injury documentation and the subsequent adoption of preventative intervention strategies will encourage

females to participate in physical activities, ensuring a safer environment, and potentially reducing the need for 

the utilization of health care services.

Amy Allina Reproductive Health Technologies Project 

Microbicide Research

My testimony focuses on the critically important task of making microbicide research an integral part of the

women’s health research agenda. Little attention has been given until recently to the need for prevention products

women can use to protect themselves against AIDS and other sexually transmitted diseases (STDs), if necessary

without their partners’ knowledge or consent. 

Seventeen years into the AIDS crisis and at a time when the incidence of STDs is reaching epidemic proportions, the single public health message to women about prevention of STDs is, “Use condoms.” For many women,

this advice is inadequate or unrealistic at best. At worst, it is life-threatening. It is only within the last few years 

that the need for woman-controlled prevention products has begun to receive the serious attention it deserves. 

Scientists are now conducting research on a variety of substances which kill or inactivate the bacteria and viruses

that cause STDs. Such products known as microbicides would allow a woman to protect herself against disease

without being forced to negotiate with her partner, as she must to ensure condom use.

There are a number of reasons why the need for microbicides is only now beginning to be recognized. First 

of all, microbicide development is not an appealing investment for pharmaceutical companies. Another barrier 

to microbicide development is that sexually transmitted diseases have only recently been recognized as a widespread problem affecting large numbers of women, and AIDS has not been considered a woman’s problem.
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Researchers working on the development of new products are pursuing some encouraging leads, and it is

absolutely critical that resources be made available so that they can continue their efforts to develop microbicidal

products. While the Reproductive Health Technologies Project commends NIH for its support of some such

research, the resources available for microbicide development are still desperately inadequate. Federal funding 

is limited, few foundations fund in this area, few pharmaceutical companies have demonstrated an interest, and 

the small companies that are currently conducting research may lack the capital to market a new product successfully. Because large pharmaceutical companies have expressed little interest in pursuing microbicide research, 

public sector collaboration is essential both for developing new product leads and for supporting the increasing

numbers of small biotech companies that are entering the field of microbicide research. 

As microbicide advocates, we will continue to expand advocacy and public education efforts to build support

for the research that is going on and to demonstrate the potential market for these products in hopes of increasing

the investment in research aimed at developing microbicides. We believe that this research should be a priority of

women’s health research because it has the potential to save and improve millions of women’s lives. Microbicidal

products will give women all over the world one more tool to protect themselves against the ravage of sexually

transmitted diseases, including HIV/AIDS.

Chief Nursing Officer

Cedars-Sinai Health System and Research Institute

Linda Burnes Bolton, Dr. P.H., R.N., F.A.A.N. National Black Nurses Association, Inc.

The National Black Nurses Association, Inc., advocates increased research funding on issues disproportionately

affecting black women and other women of color including premature labor and its sequelae of premature birth;

low-birthweight infants and infant mortality; cardiovascular disease including stroke; breast and cervical cancer;

physical and psychological trauma resulting from crime, battery, and other acts of violence; diabetes and kidney

disease; osteoporosis and other debilitative disorders; systematic lupus and arthritis; infertility; infectious diseases

including tuberculosis, AIDS/HIV; clinical depression and other mental health disorders; barriers to preventive

health care utilization and practices; and the impact of poverty, lack of access to education, and economic viability 

on women’s health and well being.

Education and Career Issues. The Association urges NIH to provide funding to increase the number of black

health professional research scientists in all fields. The number of black nurses with earned doctorates represents 

less than 1 percent of all professional nurses in the United States.

Obstetrical Care. Delayed entry into prenatal care continues to be a major predictor of low birth weight and

poor perinatal outcome. Research on stress and social support as mediating factors affecting prenatal care utilization

behavior has been funded by NIH. We require additional funding to test interventions among diverse populations

which would improve prenatal care utilization; and decrease the adverse effects of stress. Research on reduction of

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stress and the provision of community based social support services has been limited. NIH has funded research to

identify biochemical markers of stress in pregnancy (Hobel, NICHD 1994). Preliminary data indicates a correlation

between behavior in pregnancy and birth outcome. Funding is required to test interventions during pregnancy

which will decrease the incidence of poor perinatal outcome. This research has a potential significant cost savings. 

Research Across the Life Span. NIH should maintain the Office of Research on Women’s Health as a center for

sponsoring a comprehensive research enterprise. Additional funding should be allocated to support research initiatives on a comprehensive matrix of research across the life span of women including: prenatal and perinatal, childhood and preconceptual, puberty, reproductive adults, climacteric and menopausal, and postmenopausal stages. 

Research Agenda Topics. Research funding to promote the women’s health must include basic science research,

epidemiological and health outcomes research, human studies and clinical trials, nutritional and non-nutritional

dietary research, behavioral research (historical and ecological research of the effects of this factor on the risk of 

disease occurrence), organ systems and disease pathophysiology, lifestyle and health beliefs research including

social isolation, disability, chronic disease management using self care and alternative care intervention.

In summary, the National Black Nurses Association, Inc., urges NIH to increase its funding for women’s health

research on issues affecting women’s health across the life span. These include: coronary heart disease and vascular

disease, diabetes, urologic, kidney and connective tissue diseases, breast, cervical and ovarian cancer, osteoporosis,

functional disability, preterm labor and its sequelae, physical, psychological and emotional abuse, alcohol and substance abuse, infectious diseases, obesity and eating disorders, depression and mental disorders, poverty, violence,

and crime and their effects on human potentiation. 

Establish an effective recruitment and retention strategy to increase the number of women from diverse cultures

included in NIH-sponsored clinical research trials; increase community access to NIH-sponsored clinical treatment

centers; encourage partnerships between professional societies, community agencies, and NIH principal investigators to assure inclusion of culturally diverse human subjects; increase funding for NIH training grants for master,

doctorate and post doctoral research scientists, provide funding for ORWH technical assistance workshops to 

be held at national conferences; and develop a public-private partnership to fund an integrated, comprehensive

research agenda which addresses the breadth of social, environmental, physical, pathological, psychological, and

behavioral issues which impact the health of women.

University of Health Sciences

Lori A. Boyajian, D.O. College of Osteopathic Medicine

The University of Health Sciences College of Osteopathic Medicine supports the advancement of women’s

health through research. This includes, but is not limited to research into all aspects of women in biomedical

careers, medical school curricula, establishment of postdoctoral training in women’s health and the continuing

medical education of professionals about women’s health. We recognize the difficulties establishing norms for 
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education and research but we also understand that we can help establish changes that will affect the health 

of women for generations.

We believe that some basic concerns be addressed in order for effective changes to be implemented. 

These are all interrelated and interdependent. The main points of the testimony are:

1. The development of medical school curricula to address women’s health.

2. The encouragement of women to enter academic medicine.

3. The establishment of postgraduate training programs in the form of residencies and fellowships.

4. The continued education of practicing clinicians about women’s health.

5. The establishment of departments of women’s health in all medical schools.

6. The establishment of a speaker’s bureau to disseminate information to schools and professional 

societies and associations about women’s health.

Departments of Psychiatry and Internal Medicine

Joel O. Brende, M.D. Mercer University School of Medicine

Psychological Trauma in Women Seeking Help for Emotional and Medical Problems

The literature as well as my personal experience points to the fact that many patients, particularly medical

patients who have moderate levels of anxiety and depression, suffer from unresolved traumatic experiences. These

problems remain undetected and untreated, in part because physicians tend not to ask their patients questions 

pertaining to prior stressors, violent traumatic experiences, or related posttraumatic symptoms. 

Recognizing the need to integrate psychosocial and medical diagnosis and treatment, the Departments of Internal Medicine and Psychiatry at Mercer University School of Medicine have initiated a training program for internal

medicine residents to improve their interviewing and listening skills. They are being taught that it is important to

learn how to ask the right questions empathically, listen with sensitivity, and assess their patients’ histories of trauma and stress so that appropriate treatment and/or referral may be forthcoming. We have now added a Behavioral

Medicine Clinic wherein medical patients with depression, anxiety, and chronic pain are being evaluated more thoroughly by residents who are also learning the use of a trauma assessment. The results have been very positive and

patients appear to be responding with more rapid recoveries in some cases, reduced need for pain medication in

other cases, and less frequent medical visits in many. As a result of this success, a collaborative research project 

is planned in order to evaluate this diagnostic and treatment process more thoroughly.

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We are hoping that this new program and proposed research will provide information that will help to 

improve training programs for medical personnel and also provide data about the effectiveness of improved 

diagnosis and treatment of medical patients with emotional problems.

Evelyn J. Bromet, Ph.D. Sjögren’s Syndrome Foundation Inc.

Sjögren’s syndrome has been described as the most prevalent of the autoimmune disorders, afflicting 2 to 4 million patients, primarily women. Yet, most scientists and lay people have never heard of Sjögren’s syndrome, and

physicians often misdiagnose it even when the symptoms, clinical history, and laboratory tests point to this disorder. This presentation, on behalf of the Sjögren’s Syndrome Foundation, suggests that we redress the general

ignorance about the etiology, clinical detection, and treatment of this disorder with the Sjögren’s Medical Awareness Research and Treatment Program, or S/MART program. The “S” stands for Sjögren’s syndrome, a chronic,

potentially debilitating, progressive, incurable disorder with characteristic features of severe dry eyes and dry

mouth, along with extreme fatigue, frequent low-grade fever, joint and muscle pain, irritable bowel, sleep problems, and weakness. It can occur alone (noted as primary Sjögren’s syndrome) or comorbidly with other autoimmune diseases (or secondary Sjögren’s syndrome). In the worst case scenario, it can lead to lymphoid malignancy.

The “M” and “A” stand for medical awareness. Although no formal studies have documented the extent of the

underdetection by primary care physicians, anecdotal evidence combined with an average 5 to 10 year period of

help-seeking before obtaining a diagnosis suggest that the medical community is very poor at detecting Sjögren’s

syndrome. Changes in the medical and dental school curricula, inclusion of chapters on Sjögren’s syndrome in new

books on women’s health, and educational programs at local and national conferences for dentists and physicians

emphasizing the symptoms and medical management of this disease should be implemented. The “R” stands for

research: basic, clinical, epidemiologic, and behavioral. Sjögren’s syndrome has been as underresearched by biomedical researchers as it has been underdetected by medical professionals in part because it cuts across a number 

of NIH institutes, and thereby falls between the cracks. The paucity of epidemiologic research is particularly egregious. Disagreement on diagnostic criteria has been one excuse for the lack of clinical research. In reality, the different criteria sets overlap considerably, and biological markers exist for this disease. Thus, the research aim of the

S/MART program has as its fundamental goal the promotion of active, interdisciplinary basic and clinical research

aimed at understanding the etiology and course of this disease. The last letter, “T,” stands for both treatment and

team, because Sjögren’s syndrome requires a team approach to treatment. We need both interdisciplinary and innovative treatments for the symptoms we endure, and most of all, we desire a cure. Currently, we can only treat

symptoms as they arise because there is no treatment for the disease. We need to bring attention to the treatment 

of this disease through NIH-sponsored conferences, requests for grant applications, adding experts on Sjögren’s

syndrome to study sections, and working with pharmaceutical companies. Thus, we emphatically urge NIH to 

be the leader in the development of the S/MART program.
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Director, Division of Gynecologic Oncology

University of Maryland Medical School

Sandra E. Brooks, M.D. The Society of Gynecologic Oncologists

The Society of Gynecologic Oncologists (SGO) is the only national medical specialty devoted to the study 

and treatment of women with reproductive organ cancers. There are three main gynecologic cancers: (1) cervical, 

(2) uterine, and (3) ovarian. The incidence of each of these cancers and the women developing these diseases 

are different, reflecting the unique biologic characteristics of these diseases.

Both the incidence and mortality for invasive cervical cancer have declined steadily in this country over the 

last three decades. Although only 14,500 women will develop cervical cancer in 1997, a third of them will die 

from this preventable disease. African-American women continue to experience an incidence rate that is nearly 

two times higher than the incidence rate for white women, and African-American women have a 56 percent 

5-year survival rate as compared with a 70 percent survival rate for white women. 

Cancer of the uterine corpus or endometrium is the fourth most common cancer among U.S. women and 

is the most common invasive gynecologic cancer. An estimated 34,900 women will be diagnosed with uterine 

cancer in 1997. Fortunately, this cancer causes a limited number of deaths, as evidenced by a 5-year survival 

rate of 83 percent.

In 1997, the American Cancer Society estimates 26,800 new cases of ovarian cancer will be diagnosed in 

this country and 14,100 women will die from ovarian cancer this year. A relative survival rate of 90 percent can 

be achieved if ovarian cancer is diagnosed early, but unfortunately, 70 percent of women with ovarian cancer are 

not detected until the cancer has reached an advanced stage, which has an 80 percent fatality rate. The risk of a

woman developing ovarian cancer is three to five times greater if her mother or her sisters had or have ovarian 

cancer. Women who have been diagnosed with breast cancer are 70 percent more likely to develop ovarian 

cancer than the general population.

Given these statistics, the SGO would like to share with the Office of Research on Women’s Health some 

areas that need attention and hold great scientific promise if appropriate funding and research efforts are directed

towards these issues.

The SGO urges ORWH to work with Dr. Klausner to ensure the creation of a Division of Gynecologic 

Oncology within the surgery branch of the intramural program at NCI. At a minimum, this division should 

include three independent labs, where the primary investigators are fully trained gynecologic oncologists.

The SGO is advocating that additional federal resources be directed towards increasing clinical trials for 

ovarian cancer prevention and detection.

The SGO asks ORWH to take a greater role in encouraging research directed at cancers of the reproductive 

system. One way to do this is to have ORWH dedicate a small portion of their budget, to partner with NCI to 

administer a young investigator program in gynecologic oncology research.

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Prevention Research Center

Ross C. Brownson, Ph.D. St. Louis University School of Public Health

Increasing Physical Activity Among Minority Women in the United States

Decades of research indicate that physical activity is an important health promoting and disease preventing

behavior. Physical activity has been shown to lower risks of heart disease, hypertension, diabetes mellitus, some

types of cancer, and osteoporosis.

One population that appears to be particularly vulnerable to hypokinetic-based risks is minority women. 

Limited information available indicates that minority women are less likely to be involved in physical activity 

than their white counterparts. In order to increase the prevalence of physical activity in this population, several

research areas need urgent attention.

1. Assessments: Most of the assessments used to measure physical activity were developed and tested on 

white men. Extrapolating male test results to their female counterparts may result in serious limitations 

in data analysis. Research is needed to develop appropriate assessment tools and implementation plans.

2. Identifying Barriers and Determinants: Women, particularly minority women, have very different life situations than men. Research is needed to identify specific barriers and determinants of physical activity if

interventions with this population are to be successful.

3. Community Interventions: Community interventions addressing the specific needs of women are necessary.

Policy changes that promote physical activity in communities may also help increase the prevalence of

physical activity in women.

There is a shortage of well-known strategies for increasing physical activity in minority women. Development and implementation of these strategies will greatly benefit the health of our nation.

President and Chief Executive Officer

Alan P. Brownstein American Liver Foundation

Women’s Health and Liver Disease

The American Liver Foundation (ALF) is a national voluntary health organization dedicated to the prevention,

treatment and cure for all liver diseases through research and education. Certain liver diseases have a disproportionate impact on women. The most significant diseases in terms of mortality and morbidity are primary biliary 

cirrhosis (PBC), autoimmune hepatitis, and hepatitis B.
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Primary biliary cirrhosis (PBC) is a chronic liver disease that causes slow, progressive destruction of bile ducts in

the liver. Women are affected ten times more frequently than men. It is estimated that as many as 100,000 women

are living with PBC, most of whom are undiagnosed. This disease advances slowly, is chronic and often leads 

to life-threatening complications. Once cirrhosis develops the only viable treatment is liver transplantation.

Autoimmune hepatitis is a progressive inflammation of the liver. It was first described in 1950 as a disease 

of young women, associated with increased gamma globulin in the blood and chronic hepatitis on liver biopsy. 

Seventy percent of all cases of autoimmune hepatitis are women. This disease is chronic and usually increases 

in severity over time resulting in possible liver failure. Liver transplantation is the only treatment of choice 

at the later stages of the illness.

Hepatitis B is a virus that causes the liver to become inflamed. It is estimated that 125,000 people contract this

serious disease each year. Hepatitis B is responsible for 5,000 deaths annually, including approximately 1,500 from

primary liver cancer and between 350 and 450 from fulminant hepatitis. Both men and women are at risk for contracting hepatitis B, however, women have the added risk of passing the virus on to their newborn children. It is 

estimated that 22,000 pregnant women in the USA each year are infected with the hepatitis B virus, an increase

from the estimated 17,000 in 1991. Up to 90 percent of neonates of women who are carriers of hepatitis B 

become infected with the virus. Of the infants who develop chronic hepatitis B, one out of 12 will die prematurely of cirrhosis or liver cancer before they are 40 years old.

The Future for Women’s Liver Diseases

The ALF is dedicated to preventing, treating, and curing liver diseases through research and education. 

The significant liver diseases that disproportionately affect women are problematical in that they are difficult 

to diagnose, often go untreated for long periods of time because there are no signs of illness and result in life

threatening outcomes. For a majority of the women infected with any of these liver diseases the prognosis is poor.

They look forward to debilitating symptoms as the diseases progress, resulting in liver transplantation or death.

The ALF recommends that a research strategy be developed that includes basic science and clinical trials 

so that we may gain a better understanding of PBC and autoimmune hepatitis. This includes:

• Research in the areas of drug trials, involving a large number of patients around the world, exploring 

the potential use of several medications to lessen the symptoms produced by these diseases and the 

control of liver damage.

• Research into the causes and treatment for liver diseases affecting women.

The ALF recommends education be conducted with both the public and professionals, education to improve

women’s awareness of the physiological functioning of the liver and the role it plays in many of the functions of the

body. This is of particular importance for women of childbearing age who may have been exposed to hepatitis B

virus, because a highly effective treatment is available for newborns.

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• Educate women as to the risks they face as women when their livers are threatened with any one of these 

diseases. Through increased awareness women may be able to help advise their primary physicians as to 

signs and symptoms that could lead to earlier diagnoses and possibly preventative treatments to forestall 

the complications of sever liver damage and mortality.

• Educate primary care physicians about the signs of these diseases so as to lead to earlier diagnosis and

improved outcomes for women.

The ALF recommends that more research into the causes and treatment of these diseases be conducted. Further, more education into the prevention of liver disease and awareness of the signs and symptoms be done with 

the general public and in the professional medical community. These diseases produce debilitating symptoms 

and the outcome is usually death or liver transplantation. Hopefully, more can be done to alleviate the suffering

endured by women affected by these diseases.

Jacquelyn Campbell, Ph.D., R.N., F.A.A.N. The Johns Hopkins University School of Nursing

The Effects of Intimate Partner Battering on Women’s Physical and Mental Health

Battering is defined here as repeated physical and/or sexual assault by an intimate partner within a context 

of coercive control. The emotional abuse that is almost always part of the coercive control also has serious psychological consequences according to women themselves, but the actual effects on women’s health have seldom been

measured separately. In the most recent national population-based prevalence study of battering, 8 percent of

women said they were currently being physically abused.

The forced sex aspect of battering is directly associated with significant health problems with approximately 

40 to 45 percent of all battered women forced into sex by their male partners. Relationship sexual abuse probably

results in the increased pelvic inflammatory disease, heightened risk of sexually transmitted diseases, including

HIV/AIDS, vaginal and anal tearing, bladder infections, sexual dysfunction, pelvic pain, urinary tract infections,

unexplained bleeding, unintended pregnancy, and other genital-urinary-related health problems documented for

battered women in several population-based, shelter, and health care setting studies. 

Pregnancy can be a direct result of forced relationship sex, and abuse during pregnancy a continuation of the

general battering. Health-related correlates of abuse during pregnancy included substance abuse, smoking, less 

than optimal weight gain and eating an unhealthy diet. In terms of pregnancy outcomes, at least three studies 

have documented an association of low birthweight (LBW) with abuse during pregnancy, even controlling for 

other risk factors, although other studies do not show the same association.
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Other physical health problems and health care seeking of physically battered nonpregnant women are also 

well documented. In two population-based national surveys, women physically abused by a spouse or live-in 

partner were significantly more likely than other women to define their health as fair or poor. Abused women 

were also more likely to say they had needed medical care but did not get it, and severely battered women had

almost twice the number of days in bed due to illness than other women. In the Bowker survey of self-identified 

battered women who had successfully ended the violence, the majority of women had sought help from medical 

professionals, a higher proportion than from other sources of help.

Injury is the most obvious health effect of battering. Other symptoms and conditions shown in controlled

investigations to be associated with physical violence from intimate partners may be stress, including chronic irritable bowel syndrome, digestive problems, eating disorders, and other stress-related physical symptoms. Other

physical conditions such as hypertension may also be related to abuse. Although suppression of the immune 

system from chronic stress has been investigated in other populations, the role of stress in the etiology of the 

frequent communicable diseases of battered women and their children has not been investigated.

Mental health sequalae to abuse are significant and prompt women to seek health care services as frequently 

as for physical health problems. In controlled studies from a variety of settings, battered women are consistently

found to have more depressive symptoms and significantly higher diagnoses of major depression than other

women. Higher rates of post traumatic stress disorder (PTSD) have also been documented in battered women 

in shelters than in other women. The prevalence of PTSD in battered women in the general population is also 

higher than for nonabused women. Battered women would generally not complain of PTSO per se to a health 

care provider, but rather of sleep disorders or stress. Thus, there is substantial probability of misdiagnosis or 

lack of diagnosis of PTSD by mental health providers.

Substance abuse is frequently seen as part of a trauma response and abuse of both alcohol and illicit drugs 

has been found as a substantiated correlate of abuse during pregnancy. Clearly substance abuse treatment programs for women need to address domestic violence, as are shelter programs becoming more inclusive of substance abusing battered women in their interventions.

Clearly, intimate partner violence is a significant health problem that interfaces with many of the other most

important women’s health problems. Funding for violence against women research is currently concentrated within

CDC and NIH, but neither of those agencies investigate systematically the interface of intimate partner abuse and

other major women’s health problems. Therefore, the institutes of NIH need to have this area of investigation 

considered as a significant issue for research.

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Molly S. Chatterjee, M.D. Meharry Medical College

American Women of East Indian Origin in Academic Medicine

American society has become diverse. Academic medicine has faced the challenge of this diverse society. The

purpose of this testimony is to voice the concern of American women, particularly of East Indian origin. Underrepresentation of this ethnic group is reflected in the advisory panels of ORWH, NIH, AAMC, and the nation’s 

125 medical schools. These women are discriminated against and harassed in academic medicine. The process is

usually adopted by male middle managers who are unfair, egoistic, unprofessional, and self-centered. Harassment 

is encountered by these women from secretarial and administrative staff with support of these middle managers.

The legal field does not encourage these women to fight legal battles. They are advised that discrimination and

harassment are hard to prove. As such, the “chairs” of these departments have taken a ploy for “genocide.” Statistics clearly show the unequal distribution of women in hierarchy in general. This is glaring when it comes to

women of East Indian origin. A list of multiple problems involving these women have been collected and analysis

shows that history is being repeated throughout the nation. The solutions put together by different role models 

and organizations are to be applauded; their implementation remains problematic.

In conclusion, as academic medicine moves to the next millennium, the only choice this country has is to

make the leadership diverse. This can only be achieved by recognition, reward, and ethical, professional, and fair

treatment of all under-represented minority women faculty. Time has come to understand the need to include

American women of East Indian origin in leadership positions of academic medicine. I hope this public testimony will challenge the stereotype and improve the environment in academic medicine for years to come.

Bente E. Cooney, M.S.W. National Osteoporosis Foundation

I am Director of Public Policy at the National Osteoporosis Foundation (NOF), the only national nonprofit

health organization devoted to reducing the incidence of osteoporosis. New studies estimate that (1) medical

expenditures for the treatment of osteoporotic fractures is $13.8 billion, which is considerably higher than the 

previous estimate of $10 billion; and (2) that 23 million women over the age of 50 either have osteoporosis or 

are at risk of developing the disease due to low bone mass. This report includes all U.S. women, whereas earlier

reports were limited to white postmenopausal women. Another report further estimates that by the year 2015, 

the number of women affected will increase to 35 million — largely due to the aging of the population. We 

must join forces to prevent this frightening statistic from becoming a reality.

NOF asked the Research Committee of our Scientific Advisory Board to identify key areas for osteoporosis

research. The committee has not yet finalized its report, but the initial results of the committee’s work is outlined 

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Human Research. The first priority is an overarching recommendation to increase clinical research. We have

major gaps in patient-oriented research. We are not making the necessary translation from basic research to benefits available to patients. Figuring out the mechanisms of disease is very important, but once we solve the puzzle,

we tend to move on to new challenges. The solution is rarely transmitted to help the patient. This is partly because

of lack of support for this type of work, and partly because it is difficult to do. For example, there is concern that

human gene research, which mistakenly has been labeled as “clinical research,” may produce answers to questions,

but not solutions to real patient problems. Finding the gene responsible for a disease is simply not enough.

Basic Research. The number one priority should be to investigate the biology of bone adaptation to mechanical

loading. The most important research in this area is on the set point mechanism which senses loading and responds

appropriately to control the skeletal adaptive response.

In summary, the full testimony presents a partial listing of gaps in our knowledge about osteoporosis. Because

osteoporosis is such a young disease in terms of research focus and public attention, the research needs are great 

on multiple fronts. Sufficient methods for prevention, diagnosis, and treatment of osteoporosis still have not been

identified. A comprehensive national strategy to address osteoporosis including a coordinated program of basic,

clinical, psychosocial, behavioral, and epidemiologic research is urgently needed before the baby boom generation

reaches the age of osteoporotic fractures. If we fail to do so, this disease will not only bankrupt our health care 

system, but the lives of millions of women and men.

Student

Zara Cooper, B.S. Mount Sinai School of Medicine

Prenatal genetic testing is becoming an increasingly routine part of prenatal care. This trend is largely due 

to greater numbers of women having children after age 35, and rapid technological advances that have made 

testing more widely available. Additionally, current initiatives by a number of government agencies will continue 

to accelerate the general use of such testing. However, because of the inextricable link to reproductive choice and

abortion, prenatal genetic testing has not received the same amount of attention that other areas of genetic testing

have from politicians and policy makers. Consequently, our basic understanding of the complexities of prenatal

genetic testing and counseling is full of gaps. The purpose of my testimony is to describe some of the key issues 

in prenatal genetic testing, highlight areas deserving further exploration, and make a place for this issue on the

Women’s Health Research Agenda for the 21st Century.

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Brenda Crabbs Arthritis Foundation

Arthritis is the most prevalent chronic condition affecting women. Currently 23 million women have arthritis

and the number is expected to grow to 36 million by the year 2020. The cost of arthritis to our nation in lost

wages, disability payments, hospitalizations, physician visits, and medications is close to $65 billion annually 

which represents over 1 percent of our Gross National Product.

Arthritis is a serious disabling condition which discriminates against women in overall prevalence. Women

with rheumatoid arthritis outnumber men 2 to 1. In the case of systemic lupus erythematosus and fibromyalgia, 

nine women have the disease compared to one male. Given its enormous impact on women and its projected rate

of growth in the future, arthritis must have a prominent place in the women’s health agenda of the 21st century.

The economic, social, and psychological impact of arthritis on women is staggering. Arthritis is the leading

cause of disability and the second leading cause of disability payments. Studies indicate that approximately half 

of patients working when diagnosed with rheumatoid arthritis become disabled within 10 years, suffering substantial earnings loss. Arthritis is the condition reported by women as the leading cause of physical limitations 

in activities of daily living. The impact of arthritis on psychological status has been noted in terms of depression,

coping strategies, anxiety, cognitive changes, self-efficacy, and learned helplessness.

Several research advances within the last 10 years stand out for arthritis patients. The use of methotrexate 

as a safe and effective long-term treatment for rheumatoid arthritis has successfully controlled symptoms and

reduced the need for steroids in adults and children. Advances in genetic research, Lyme disease recognition 

and treatment, and joint replacement technology are considered among the most important in improving the 

lives of arthritis patients.

Perhaps the most significant gap for women in arthritis research is the role of genetic makeup and hormones.

Most researchers believe that the triggers for arthritis are in a woman’s physiologic makeup. Could a woman’s body

structure designed to bear children be a contributing factor to the cause of osteoarthritis? Even more significantly, 

are hormones responsible for the autoimmune forms of arthritis such as lupus and rheumatoid arthritis that so 

predominately attack women? Is there a single arthritis gene or are a combination of genes involved? Finding 

the answers to these questions will provide critical clues to finding a cure for arthritis.

Of critical importance to the Arthritis Foundation is the use of comprehensive measurements to evaluate

research outcomes in the lives of women. Outcome measures that have meaning for women with a chronic disease

such as arthritis must include a measurement of functional status and an assessment of their quality of life. These

outcomes must be realistic and relevant to women’s lives. They must be developed to apply for a period of decades

rather than months and they must place value in slowing the rate of decline in functional levels rather than maintaining functional status. It is imperative that good outcome measures in women’s health research in the 21st 

century are quantifiable, include the patient and consider health status in terms of a woman’s ability to function 

within roles of critical importance to her over the extended term of her life.
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Chief, Shoulder Service

Hospital for Joint Diseases

Frances Cuomo, M.D. American Shoulder and Elbow Surgeons

American shoulder and elbow surgeons are confronted with a vast and varied number of pathologies relating

to the shoulder that are quite specific to females. These disorders are responsible for significant economic loss,

medical cost, and emotional and physical burden that profoundly affect not only women but the population as 

a whole. The three most common disorders related to the shoulder which primarily affect females include osteoporosis-related proximal humerus fractures, frozen shoulder syndrome, and instability of the glenohumeral 

joint in teenage females. 

Proximal humerus fractures comprise approximately 5 to 7 percent of all fractures reported. The rise in 

fracture incidence with age and the higher incidence among females are characteristic epidemiologic features 

of fractures associated with osteoporosis, which should be considered an important etiology in these injuries.

Increasingly, osteoporosis-related fractures are linked to impaired vision, altered balance, decreased muscle

trophism, overall poor health, and predisposition to falls in the elderly. 

Elderly patients sustain proximal humerus fractures as a result of indirect and direct mechanisms of injury.

Whatever the mechanism of injury, treatment is based upon the degree of displacement of the fracture. Regardless of the method of treatment deemed appropriate, problems of obtaining healing, loss of fixation in soft osteoporotic bone, and stiffness plague the management of these difficult injuries. Rehabilitation of these injuries is 

prolonged, requiring at least 12 to 18 months, even in the most minimally displaced fractures. The prolonged 

post injury rehabilitation including physical therapy is a great strain for all involved.

We feel this is a very important area for focusing research. Specific areas to concentrate upon include prevention be it pharmacologic, educational, or physical rehabilitation; bone reconstitution methods once obvious loss 

has already occurred; and fracture management including improved methods of fixation and healing enhancement

techniques in bone with poor osteogenic potential. 

Frozen shoulder syndrome is a disorder that has been described as a condition difficult to define, difficult to

treat, and difficult to explain from the point of view of pathology. Adhesive capsulitis has continued to be one of 

the most poorly understood disorders of shoulder motion, posing significant challenges to the clinician. Much of 

the problem has stemmed from the fact that it has not been easy to define or clearly differentiate frozen shoulder

from conditions with similar symptoms and findings but with distinctly different causes. 

Frozen shoulder is a condition of uncertain cause characterized by significant restriction of active and passive

shoulder motion that occurs in the absence of a known intrinsic shoulder disorder. Most studies report the cumulative risk for at least one episode to be approximately 2 percent. It is much more common in women than men. 

The precise cause for the development of frozen shoulder remains largely unknown. The condition probably

results from the combination of host factors (i.e., predisposition) and extrinsic factors (for e.g., trauma, hormonal

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changes, collagen-vascular disease, diabetes mellitus). In general the natural history of frozen shoulder is uncertain,

and additional randomized, prospective studies are needed. Other main areas of research for frozen shoulder 

syndrome include its pathogenesis and efficacy of treatment options.

Last, a large group of patients suffer from what is known as atraumatic multidirectional instability of the 

glenohumeral joint, defined as instability that is insidious or spontaneous in onset with no history of significant 

trauma inducing the first episode of instability. This is very common in the teenage female. Patients often experience their first episode of instability before the age of 16 years. Why the female teenager is so much more frequently subjected to this disorder around the time of menarche and early thereafter, raises the question of a 

hormonally related phenomenon. 

Management of this difficult problem is complex and quite time consuming. Some patients respond to 

rehabilitation and others do not. Treatment programs are quite costly and time consuming as well as being 

responsible for a significant amount of time lost from school and daily activities. 

Research is sorely needed in the area of shoulder instability in teenage females. The possibility of a genetic 

predisposition versus a process which is activated during menarche and possibly hormonally related need to be

investigated. Rehabilitation is a very important area for research as well as basic science studies on the glenohumeral ligaments of the female shoulder. 

Leilani Doty, Ph.D. Department of Neurology, University of Florida

Problems in Health Promotion and Disease Prevention. Most symptoms are evaluated and treated outside the 

formal medical care delivery system by the family health gatekeeper who synthesizes lay medical knowledge from

multiple sources — personal experience with illness, vicarious experiences of morbidity in nuclear, peripheral and

public networks, and information gleaned from professionals and the media. A major gap in knowledge exists in

the area of women and family health. In particular, there is a gap in the health needs perceived by the woman who

typically is the health gatekeeper of the family unit, for it is the woman who treats the symptoms, monitors the 

trajectories of chronic disease, transmits health information, teaches health practices, secures appointments, and

administers medication. Further, there is difficulty in providing health education and services in ways that reverse

the upward spiral in health costs, prevent life span disease, and promote healthy lifestyles.

Community Partners’ Study. A creative solution to this problem lies in a model project under development in

Gainesville, Florida through the leadership of Community Partners. Community Partners links the University of

Florida faculty and students, especially from the Health Science Center, with people of diverse age and cultural 

backgrounds from the public school system, community health services; civic, philanthropic, and volunteer 

organizations; and city and county governments.
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Community Partners has combined a variety of resources to study the health needs of the most underserved,

local citizens. The study examines health needs, health behavior decision-making, household and environmental

risks and self-perceptions of health. Students from the University of Florida health professions schools teamed 

with local high school students to interview household heads and to photograph neighborhood settings to evaluate

subjective and visual-objective health. In assessing the health promotion needs of the community, the researchers

identified key members of the underserved communities to train as health messengers. After training in the Health

Promotion School, Health Messengers share their health messages with peer groups and neighbors to foster health

promotion behaviors in the community health gatekeepers, typically the woman of the family. The Health Promotion

School will train the volunteer Health Messengers to address strategies, in culturally sensitive ways, that promote

health and prevent disease over the life span.

Evaluation of Outcomes. Outcomes of the Health Promotion School will be measured through pre- and postcourse tests of changed health professional student competence in community health promotion and disease prevention, through community patterns showing use of health facilities, changes in health issues awareness, and

changes in numbers of prospective students from the community seeking entry to health-training programs. 

Research support is needed for projects that partner academic health centers with community groups in a collaboration to identify and address the cultural diversity of the community and the self-perceived health needs of 

the citizens, especially the family health gatekeeper. Empowering key members of the underserved community 

to serve as Health Messengers for peers should result in appropriate, acceptable, accessible, cost-effective ways 

to promote healthy lifestyles over the life span of women and their family members.

Thoracic Surgical Oncologist

Carolyn M. Dresler, M.D. American College of Chest Physicians

Lung cancer is the number one cause of cancer death in women, exceeding deaths from breast cancer by

22,000 per year. Between 1950 and the present there has been a 550 percent increase in the numbers of deaths 

in women due to lung cancer. In 1991, 36 percent of all lung cancer deaths were in women and by 1996, this 

had risen to 41 percent. Thus, the lung cancer death rate is decreasing in men, but continues to climb in women.

Approximately 48 million people currently smoke in the United States — 25.3 million men and 22.7 million

women. Although data suggested that smoking prevalence appeared to be decreasing as of 1991, more recent surveys

have demonstrated that the percentage of smokers has increased from 27.5 percent of students in grades 9 to 12 in

1991 to 34.8 percent in 1995. In addition, these 1995 data demonstrate that girls and boys are now smoking at

equivalent rates: 34.3 percent and 35.4 percent, respectively. This increase in the prevalence of smoking is likely 

to reflect an increase in the incidence of lung cancers in the near future, particularly in women.

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Epidemiologic studies have demonstrated that women have a 1.4 to 2.9 times higher risk of developing lung

cancer than men, when the amount of tobacco exposure is controlled. In large case-controlled studies, the odds 

risk ratios for women have been consistently higher in women than in men. Authors of these studies have hypothesized that women may be more susceptible to tobacco-related carcinogens for a given level of cigarette consumption, particularly when examined for the prevalence of the histological subtype of lung cancer — adenocarcinoma.

In addition to the risk factor of tobacco exposure, women may also be affected by their exposure to estrogens

and/or progesterones. Studies have demonstrated increased risk of lung carcinomas, particularly adenocarcinomas

in women with increased exposures to estrogens. Estrogen is a known “growth hormone,” and has been identified

as a risk factor in the development of adenocarcinomas in the breast, endometrium, and ovary.

According to the NIH Accounting Office, approximately 100 million dollars was spent in 1996 for lung cancer

research; 600 million dollars was spent for breast cancer research (300 million from NCI and 300 million from the

Department of Defense) and over 1 billion dollars for AIDS research. This allocation is inappropriately distributed

for the health and societal costs resulting from the respective diseases.

The growing epidemic of lung cancer in women is an exceedingly important health problem, not only in our

society, but of grave concern in the rest of the world. Women in exploding numbers are taking up smoking around

the world. The particular risk of women, smoking, and lung cancer is not at all understood. It is imperative that

serious, in-depth and well-funded research is directed to the multidimensional health problem of women and 

lung cancer.

Laura Flawn, M.D. The Scoliosis Research Society

The Scoliosis Research Society is a research-oriented society dedicated to the pursuit of knowledge about the

causes, cures, and prevention of scoliosis and related spine deformities. As a representative of this Society, I would

like to draw your attention to certain particular gender-specific spinal problems. Eighty percent of adult symptomatic scoliosis occurs in women. Progressive curvatures cause mechanical arthritic back pain, radicular or nerve

root pain, loss of standing or sitting balance with trunk decompensation, and possibly even neurologic deficits.

Other spine disorders affecting primarily women are spondylolisthesis (both developmental and degenerative)

and postmenopausal osteoporotic compression fractures and related deformities. These are very disabling problems

adversely affecting both quality of life and function. We would like to draw your attention to these potentially 

devastating health problems and ask your involvement in directing research and promoting education into both

treatment as well as prevention.
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The Center to Improve Care of the Dying

Janet Heald Forlini, J.D. George Washington University

As the representative for both The Center to Improve Care of the Dying and the Institute of Medicine, my testimony covers not only the policy implications of directed research on this issue, but also the recommendations and

findings of the IOM’s Committee on Care at the End of Life. The main points of my testimony are as follows:

• A discussion of why improving end-of-life care is especially important to women, given that women 

generally live longer than men and often act as care givers to ill family members and friends.

• Examples of questions that need to be asked and answered by NIH ORWH.

• A discussion of other groups, such as business owners and insurers, who could learn from research 

and data, thereby improving the chances that caregiving will not bankrupt families.

• A directive to change the emphasis of health care at the end of life to that of caring rather than curing.

• A summary of the most relevant conclusions and themes of the Institute of Medicine’s Committee 

on Care at the End of Life.

• A recommendation by the Committee, directed specifically at NIH and the research establishment 

in general.

Julie Fleming Graham, M.Ed. Oglethorpe County Primary School

I am the mother of John Mark Fite, Jr., who at the age of 7 years old, died from cancer. I am also a public

school principal in a primary school of 530 students. During the past 24 years, I have taught in eight different 

public schools and have found in each of these a common bond: children with diverse medical and special needs.

What is so alarming to me is the increase in numbers of children who need to be served by a special education

teacher for either a segment of the day or for the entire day. I am not sure if the numbers have actually increased 

or we are more educated as to the specific needs of children.

As an administrator for the past 10 years, I have had a lot of direct contact with other administrators, 

teachers, students, and their families to validate that there is a growing need in our schools to provide more 

financial, educational, and counseling support. The most important health issues impacting our children’s learning in our small school alone are: attention deficit disorder, fetal alcohol syndrome, learning disabilities, diabetes,

autism, cancer, behavior and emotional behavior disorders, asthma, allergies, mildly and moderately handicapped,

OT/PT/OHI (orthopaedically handicapped or other health impaired), conjunctivitis (pink eye), impetigo, and

pediculosis (head lice).

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Although the school did not create these illnesses, I think it indirectly contributed to some of the problem. 

We face an oppositional group who do not want the building sprayed for bugs. We face another group who want 

the building sprayed. We face a group who want carpeted classrooms and another group who, like me, believe 

carpet is a haven for germs. How can we effectively sanitize a carpeted classroom where pediculosis exists? 

These are problems we face daily.

Executive Director

Phyllis Greenberger, M.S.W. Society for the Advancement of Women’s Health Research

The Society for the Advancement of Women’s Health Research strongly supports the work of ORWH 

and believes these efforts will play a pivotal role in translating this research agenda into action across NIH. 

The Society is a nonprofit advocacy group that was formed 7 years ago in response to mounting concern 

about gender biases and inequities in biomedical research. The Society has played a vital role as a catalyst for

advances in women’s health, including strengthening policies ensuring women’s inclusion in federally funded 

clinical research and advancing the study of gender differences, which we call gender-based biology. Genderbased biology examines the differences between the genders in a cell, an organ, or an individual to discover 

what these differences tell us about the system in which they function. The Society strongly endorses the inclusion of gender-based biology research as an integral part of an updated NIH research agenda on women’s health.

Gender-based biology is a concept that could potentially revolutionize the practice of clinical medicine. Evidence is already accumulating to show that resources spent in investigating biological gender differences will be

rewarded by advances in medical knowledge and practice. For example, men and women’s immune systems function differently in a manner that leaves women more prone to autoimmune disorders, women who smoke at the

same levels as men are more susceptible to lung cancer, and several drugs such as a certain class of pain killers 

and an experimental drug to treat unstable angina have been found to have different effects in men and women. 

These examples hint at the power of gender-based biology as a research approach and the wealth of clinically

significant gender differences which might be uncovered by gender-based biology research. As this field of study 

is explored, we will enhance our understanding of how gender differences affect the manifestations of health and

disease and convert this knowledge into new and effective therapies which address the uniqueness of both women

and men. Because of the potential significance of gender-based biology research, serious attention by the scientific

and medical establishment is necessary. As the nation’s premiere biomedical establishment, NIH should play a 

pivotal role in advancing gender-based biology at all levels of research across all institutes beginning with its 

updated research agenda on women’s health.
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Letha Y. Griffin, M.D. American Orthopaedic Society for Sports Medicine

Over the past two decades there has been a marked rise in the number of women participating in recreational

and competitive sports. For example, only 96 women competed in the 1972 Olympics for the United States, whereas

in 1996, 280 women competed with the United States women’s teams making an extremely strong showing in multiple sports. Colleges are seeking to provide women with scholarship opportunities equal to men, and the number of

women athletes in our high schools rose from approximately 300,000 in 1971 to almost 2 million in 1990 — nearly a

sevenfold increase. As the number of women athletes has grown, injuries that occur more commonly in our female

athletes have received increasing recognition. These include ligament injuries of the knee, kneecap tracking problems, subluxation of the shoulder, stress fractures of various long bones as well as the pelvis and lumbar spine, and

forefoot overuse problems (corns, bunions, callouses, etc.).

Unfortunately the cause or causes of many of these musculoskeletal problems are not well understood. Until

they are, it is difficult to design adequate preventive programs. More money allocated to musculoskeletal research

would give us the financial ability to determine injury mechanisms and hence to begin to prevent these muscular

skeletal injuries which occur all too frequently in our young women resulting in significant consequences.

Andrew A. Guccione, Ph.D., P.T. American Physical Therapy Association

The American Physical Therapy Association believes that research is especially needed in the following areas:

Prevention of Chronic Conditions. (1) A continuing research emphasis is needed on the prevention of osteoporosis and hip fractures; (2) the influence of exercise and physical activity on balance activities, including the prevention of falls should be studied more extensively; (3) additional research is needed on the benefits of exercise for 

the prevention of disease and disability; and (4) research is needed to identify strategies that can be employed 

during childhood, adolescence, and adulthood to encourage women to develop good health habits.

Chronic Conditions. (1) Increased research is needed on chronic conditions and diseases that impact the quality

of life of older women in the U.S.; (2) research is needed to identify the most effective way to reduce musculoskeletal impairment and improve function; (3) research on intervention for osteoporosis, including studies on the clinical

effectiveness of weight bearing is indicated; (4) research on rehabilitation interventions which improve functional

status following stroke is indicated; (5) additional research is needed on quality of life in individuals with diabetes;

(6) research on the prevention and treatment of cardiovascular disease through cardiac rehabilitation for women is

needed; and (7) additional research is needed to improve urinary incontinence treatments, including therapeutic

exercises, electrotherapeutic modalities, and biofeedback.

Recreational and Sports-related Injuries. Investigations into the prevention, causes, and treatment of athletically

related musculoskeletal injuries, especially knee injuries, are needed.

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Environment. Attention should be given to interventions which influence the outcome of women with carpal

tunnel syndrome and other repetitive strain injuries. In particular, research is needed to identify practical, effective ways to protect workers from job-related musculoskeletal risks, including repetitive stress syndrome.

Additional Topics. (1) Biomedical research should be expanded to ensure emphasis on conditions and diseases

unique to, or more prevalent in, women of all age groups; (2) research is needed to investigate the effect of interventions, including surgery, on female anatomy as well as the impact of these interventions on women’s health; 

(3) research is needed to study the etiology and treatment of the high incidence of musculoskeletal problems in

menopausal and postmenopausal women; (4) studies that investigate how exercise can promote healthy aging 

in women are especially indicated; and (5) investigations targeting the identification of domestic violence by 

health care professionals are necessary.

Recommendations to Promote Research on Women’s Health. (1) Promote efforts to include women in clinical trials,

including choosing study site locations and hours that are conducive to participation by women; (2) promote funding

for programs that foster women’s health research; and (3) expand the mission of the Office of Research on Women’s

Health to monitor funding for women researchers and career opportunities.

Betty B. Hambleton Health Resources and Services Administration

The proportion of total AIDS cases attributable to women is increasing, rising from 7 percent in 1985 to 

20 percent in 1996. HIV infection is the third leading cause of death among women ages 25 to 44, and the leading

cause of death among black women in this age group. Black and Hispanic women are disproportionately affected,

accounting for 59 percent and 19 percent respectively of cases reported for women in 1996 — rates that are 17 and 

6 times higher than for white women. In 1994, transmission via heterosexual contact surpassed transition via drug

use; however, sexual contact with a drug injecting male accounts for the majority of heterosexually acquired AIDS

cases among women.

As the federal agency that provides health care to underserved and vulnerable Americans, HRSA focuses 

many initiatives on addressing the health needs for improving the health status of women. In addition to the community-based health centers offering primary care clinical and screening services, and support for the education

and training of the health professional workforce, special services are funded through the Ryan White CARE Act

(RWCA) of 1990, administered by HRSA’s new HIV/AIDS Bureau, to assist HIV-positive substance abusing women,

better integrate comprehensive primary care and HIV-related care, and to prevent perinatal transmission of HIV.

Title I of RWCA funds eligible metropolitan areas most severely affected by the HIV/AIDS epidemics. About 

30 percent of clients are women, many of whom participate on planning councils established to assess needs, gaps 

in care and to set priorities. Title II provides formula funding to States and territories to improve quality, availability

and accessibility of health care and support services for people living with HIV disease; nearly 28 percent of these
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clients are women. Under Title III, public and private nonprofit entities are funded for outpatient primary care and

early intervention services. Of 83,000 HIV patients receiving health services, 794 were pregnant women. An assessment is underway of current HIV counseling and testing services delivered to women of childbearing age and pregnant women in the Community and Migrant Health Center, Health Care for the Homeless, Health Care for Residents

of Public Housing, and other programs administered by HRSA’s Bureau of Primary Health Care. Title IV funds public and nonprofit entities to increase access to research and comprehensive, community-based systems of care for

children, youth, women and their families. About 53 percent of the clients are adolescent or adult women, and

more than 25 percent of newly enrolled clients are pregnant women and mothers. The Women’s Initiative for HIV

Care and Reduction of Perinatal HIV Transmission develops models of care that enhance outreach, counseling and

testing services for women. In 1996, the network of projects provided counseling to more than 12,000 women.

The education of primary health care providers about HIV-related issues is carried out through HRSA’s

National AIDS Education and Training Centers Program. More than 400,000 providers have been trained 

under this program since 1991.

HRSA will continue to monitor changes in health needs of women with HIV/AIDS. Research will be carried 

out to better understand the utilization and effectiveness of its programs and services on the behavior and health

status of these women.

Jo A. Hannafin, M.D., Ph.D. Orthopaedic Research Society

The Orthopaedic Research Society is an organization of close to 2,000 individuals (M.D.s and Ph.D.s) who conduct research on the musculoskeletal system. Dr. Hannafin, an orthopaedic surgeon specializing in sports medicine,

as well as a researcher studying tendon and ligament healing, provided information on the role of women in the

Research Society and in the Orthopaedic Research Community, and presented data on the advances and unanswered

questions pertinent to the Women’s Health Initiative. Specific areas for which additional research is needed are: 

• Osteoporosis, especially in the younger woman, a field in which there are numerous questions.

• Injuries in the female athlete, with emphasis on increasing numbers of women in sports and recent data 

on the types of injuries, and the questions that must be addressed in the future.

• Musculoskeletal consequences of breast cancer therapy, with insights into the advances that have been 

made in the treatment of breast cancer, and the established effects of some of these therapies on bone.

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Wayne State University

Susan Hendrix, D.O. Detroit Medical Center

I am an Obstetrician/Gynecologist representing Wayne State University and the Detroit Medical Center. I am

the Principal Investigator of the Women’s Health Initiative, Detroit Clinical Center, and Director of the Medical 

Center’s Center of Excellence in Women’s Health. I would like to add three areas to the future research agenda 

in women’s health. 

Ectopic Pregnancy. Ectopic pregnancy, the implantation of the fertilized egg outside the uterine cavity, is the

most common cause of maternal death in the first 12 weeks of pregnancy. Ectopic pregnancies have increased 

nearly approximately threefold from the 1970s to the 1990s. The increase is attributed to many factors, including 

an increasing incidence of pelvic inflammatory disease, use of tubal reconstructive surgery and assisted reproductive technologies for infertility, use of tubal ligation for sterilization, and use of intrauterine devices. The annual 

cost of ectopic pregnancy in the United States exceeds $1 billion. 

Highly sensitive blood tests for detecting pregnancy hormone have allowed clinicians to identify and treat 

this condition earlier in its course. Surgery is a major treatment for patients desiring future fertility. Ultrasound

combined with blood tests allows patients to avoid surgery and its complications, reduces health care costs by

reducing the need for hospitalization, and possibly improves long-term fertility. Studies are needed to determine 

the most effective and safest treatment of ectopic pregnancy, as well to determine which treatment affords optimum potential for future pregnancies. 

Pelvic Prolapse. Genital prolapse (the detachment of the uterus, vagina, rectum, and bladder from their normal

support) is a common condition in women. It is not clear who will develop pelvic prolapse or why, but the condition

progressively worsens with age, and prevention measures at an early age are impeded by difficulties in identifying

patients at risk. Little is known about the risk factors. Surgical management of this condition is the gold standard.

However, more research is needed to better understand the causes of this condition and ways to prevent it.

Alternative Menopausal Treatments. Because physicians cannot answer their health questions, menopausal

women are taking matters into their own hands. They want coordinated, comprehensive and preventative health

care that is based on cutting-edge research. For many women traditional approaches to the treatment of menopause are unacceptable. They are turning to alternative treatments, including phyto-estrogens and herbal remedies,

for symptom relief or disease prevention. However, “natural” does not necessarily mean safer or better treatment.

The strength of plant products can vary and there is no quality oversight to the production of these products. 

Only clinical trials on the safety and efficacy of these products will answer that question.
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Mary Hepburn, B.S. Self

Many obstacles in health affect how any disabled woman reacts during her life, as I described during my 

testimony about research on women’s health for the 21st century. My experiences with multiple sclerosis presented

me with daily challenges and many obstacles along the way. There are many obvious and not-so-obvious changes —

physical, emotional, and spiritual that occur. Not only did I have to deal with physical limitations of multiple sclerosis, but the mental transition couldn’t be avoided. These created a lot of turmoil for the individual and the family,

caused chaos, and sometimes total frustration. With MS, a person’s coping skills become a major challenge.

Nicolette Horbach, M.D. American Urogynecologic Society

The American Urogynecologic Society (AUGS) is a medical specialty society composed of over 700 members

who specialize in providing the continuum of care to women with disorders of the pelvic organs including the 

diagnosis and treatment of urinary and fecal incontinence, pelvic organ prolapse, infections, and voiding disorders.

• Prevalence statistics regarding the number of women suffering from disorders of the pelvic floor are difficult 

to ascertain because of significant under-reporting of these conditions.

• It is estimated that 50 percent of parous women lose pelvic floor support, resulting in prolapse. Of these

women only 10 to 20 percent seek medical care for their symptoms. The overall prevalence of all causes of 

urinary incontinence is reported to be approximately 40 percent less. Less than one half of women with incontinence report their symptoms to their health provider, and most wait at least 5 years before seeking care.

• The National Center for Health Statistics reports that nearly 400,000 operations are performed annually for 

these conditions. Recent research suggests that women have a 11.1 percent lifetime risk of undergoing a 

single operation for pelvic organ prolapse and/or urinary incontinence.

• The estimates regarding the direct costs of urinary incontinence have increased from $10 billion in 1987 

to $16 billion in 1994. Only 4 percent of these dollars is used for the diagnosis and treatment of urinary 

incontinence. The remainder was spent on management of the problem.

I would now like to share with the Task Force three activities that the American Urogynecologic Society 

feels will help to uncover new knowledge that will improve the health of women with pelvic floor disorders.

• The first is to convene an inter-Institute working group in the area of pelvic floor dysfunction research.

• The second is to work with NIH to find a mechanism and funding source to support training and 

career development awards for new and young investigators interested in careers in incontinence 

and pelvic dysfunction research.

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• The third objective is to assist NIH in developing an RFA in FY 1998 with the intent of funding 

three to five small pilot grants in the area of incontinence and pelvic floor research.

Ruth Jackson Orthopaedic Society

Mary Lloyd Ireland, M.D. Kentucky Sports Medicine Clinic

Mobility: A Key Ingredient for Enhancing the Quality and Length of Women’s Lives

Women must adopt an active lifestyle if they are to maintain good physical and mental health. Yet there are

many threats to a woman’s mobility. Societal biases still hamper women’s opportunities to participate in and enjoy

athletic activities. Women’s physical and anatomical differences from men have not been fully appreciated by coaches

and trainers, placing girls at unnecessary risk of pain and injury. As women age, they undergo the special stresses of

mineral-depleting osteoporosis and become vulnerable to many kinds of fractures. Hip fracture represents an especially important risk to women since it has such a serious impact on independence and quality of life.

Women’s tendency to become less active with age exacerbates their susceptibility to a myriad of health problems including obesity, heart disease, depression, and diabetes. Inactive women often become trapped in a downward spiral of poor health and immobility. The loss of a woman’s mobility often results, directly or indirectly, in 

her premature death.

Physical activity is a critical element of a healthy and satisfying lifestyle. We must learn more about how to

promote movement among women, and how to circumvent the social and biological processes which threaten 

their mobility.

Anne Kasper, Ph.D. Boston Women’s Health Collective

Our definition of women’s health includes women’s experiences with their bodies and their sexuality, and their

interactions with the health and medical care system, as well as specific biologic conditions or diseases mostly

affecting women. Our work, in the public interest, is to empower women by providing them with the best information available. We support them with providers who respect and encourage their participation and responsibility.

We have focused on the normal in each life stage and reproductive transition because so much medical information

has focused on diseases, or defines normal life transitions as inherently deficient, and unmanageable without medical intervention and surveillance. We research and describe nonmedical, self-help approaches as well as medical

treatments, believing that true informed consent includes both. From the start of our work we have named race

and class, along with gender and sexual preference, as key determinants of health, and important human rights
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concerns. We are advocates for women who use the system, and work with professionals and consumers who organize to change it. We call for greater roles for women in governance of a system which impacts them so profoundly,

since that system depends on women’s unpaid caregiving on behalf of ill family members. We bring a critical lens 

to the conduct of research and the practice of medicine, and actively pursue evidence of treatment effectiveness as

essential to rational decisionmaking. Our scrutiny of the doctor-patient or practitioner-patient relationship has

intensified under managed care since providers working under these plans may no longer be able to give the best

advice and information. As we work with the media, we bring feminist, gender analysis to health issues whose

impact is often distorted by gender-neutral or color-blind approaches, or biased by special interest.

We call on ORWH and NIH to research methods for dissemination of information about determinants of

health, normal processes of development across the life span, and the importance of evidence-based perspectives 

in health and medical decisionmaking. This research includes finding methods to disseminate the ineffectiveness 

or potential harm and abuse, and to illuminate ethical issues, as well as reporting the effectiveness of biological

research or treatment approaches. We cite examples from maternity care, gene research, development, and use 

of medical technology (especially in normal women), diet and exercise benefits, smoking in girls, the impact of

poverty and social class on mortality, women’s overwork in the workplace and home, barrier method contraception, and nonmedical approaches to HIV/AIDS care, in order to illustrate how additional research is needed to

examine the impact of research and the implementation of research, on the lives of women from a variety of 

backgrounds. We also call for greater utilization of methodologies already in use, or piloted recently, such as 

Consensus Development Conferences and the Urban Women’s Health regional “Report Cards” to provide 

research issues with greater community perspective and input.

Marlene Keeling Chemically Associated Neurological Disorders (CANDO)

Exposure to chemical toxins has become an urgent global problem. Much of our knowledge regarding neurotoxicity of specific chemicals has not been found in the laboratory but rather has come from outbreaks of human

neurotoxicological disease due to excessive environmental and industrial overexposures resulting from both accident or ignorance. With methyl mercury and PCBs, neurotoxicological illness was not restricted to the adult 

population; children born to exposed mothers also suffered lasting neurological and behavioral effects. 

It is now commonly accepted that the developing nervous systems in the unborn child are especially sensitive

to chemical toxicity. Research on lead, alcohol, methyl mercury, and PCBs indicate that infants and children may 

be at an increased risk of exposure in the womb and during breast feeding. 

As we approach the 21st century, I urge ORWH to focus research on one source of probable chemical toxicity 

that has not been adequately researched — silicone implants — which includes toxic chemicals known to have 

neurologic, carcinogenic, and teratogenic effects in exposed mothers and their unborn children. This issue affects 

so many women and their unborn children. Silicone, silica, and its components have not only been used in

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implantable devices but are used in cosmetics, medicine, food, needle tips, and hundreds of other products.

Research now clearly shows that it is not inert in the body, as previously purported by the chemical industry. 

With more than 100,000 implanted women having been diagnosed with severe illness, this is the time to 

do the critical research that should have begun thirty years ago. Some of the serious problems seen in many

implanted women include peripheral neuropathy, demyelinating neuropathy, atypical neurological disorders, 

cognitive dysfunction, organic brain disorders, and immune dysfunction. Silicone has the ability to produce 

human hypersensitivity in as high as 26 percent of implanted patients. The following questions should 

be answered: 

1. Is silicone or silica a soluble neurotoxin? 

2. What part does silicone or silica play in the incidence of chronic illness? 

3. Does silicone, silica, or its components pass through the placenta and breast milk with 

harmful consequences?

4. Does silicone, silica, D4, or other components act as a synthetic estrogen or estrogen blocker 

as industry research has reported?

5. Do the reports of increasing cases of multiple myeloma in young women with breast implants 

indicate a cancer latency factor?

Gwendolyn Puryear Keita, Ph.D. American Psychological Association

On behalf of the American Psychological Association (APA), I would like to convey our deep appreciation 

for recognition of the importance of psychosocial and behavioral and social scientists in the development of 

the new women’s health research agenda.

Despite increased focus on medical and epidemiological aspects of women’s health, research has not adequately addressed psychosocial and behavioral factors that contribute to health status. In May 1994, APA 

in collaboration with a number of federal agencies and professional organizations sponsored an interdisciplinary conference titled “Psychosocial and Behavioral Factors in Women’s Health.”

The “Research Agenda for Psychosocial and Behavioral Factors in Women’s Health,” which evolved out of the

conference, was developed by experts from across disciplines, institutes, and federal agencies. It defines research

priorities pertaining to specific diseases and health practices that greatly affect women. The diseases included are

those that show high mortality or morbidity rates for women and that may cause great physical disability, lowered

financial resources, and poorer quality of life.
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APA believes that consideration of future research and funding needs for women should be made (1) with 

full awareness of the issues of concern to women’s health, (2) with knowledge of what research has already shown,

(3) with knowledge of what questions remain unanswered, and (4) with a full appreciation of the behavioral and

psychosocial factors that impact each health issue. Our research agenda was developed with these factors in mind.

We, therefore, propose that ORWH use our research agenda as a foundation upon which ORWH builds its new

research agenda. This would avoid duplication of efforts and enable women’s health researchers, federal agency 

personnel, and policy makers to most effectively address women’s health research and would go a long way in 

furthering the much-needed federal commitment to improving the health of America’s girls and women. 

Copies of the research agenda are readily available for your use.

Ann Kolker Ovarian Cancer National Alliance: Ovar’coming Together

The Ovarian Cancer National Alliance, formed last spring, is the creation of leaders from the growing number of ovarian cancer groups across the country. These groups united to establish an umbrella group, the Alliance,

because they believe that it is essential to have a coordinated effort that will put ovarian cancer policy, education,

and research issues squarely on the agenda of national policy makers and leaders in women’s health. This conference is our public debut.

I have a straightforward message. It is urgent that researchers, clinicians and policy makers dramatically

expand awareness of and resources devoted to ovarian cancer with the goal of significantly improving early 

detection. The tragedy of ovarian cancer is that more than 50 percent of the women who have it die within 

5 years of diagnosis, because the vast majority of women are not diagnosed until the cancer has reached 

late stage, when it is too late to cure. 

There are several reasons for this serious state of affairs. One is that awareness of ovarian cancer in the 

medical community is limited. Because it is not a common disease — affecting only 1 in 55 women — it is 

not “on the screen” of many primary care doctors who first see women who report abdominal discomfort, 

bloating, bleeding or some of the other common symptoms. Gaining the attention of the medical community 

about ovarian cancer is a top priority of the Alliance. Another concern is that many at-risk women are unaware 

of symptoms, which are often subtle and not unique to ovarian cancer. Thus, another Alliance priority is to educate women about this disease, so that when symptoms occur, women request appropriate testing. The third 

problem that dooms so many women to late-stage diagnosis is the imperfect status of diagnostic tools and the

absence of a simple, cost-effective, and reliable screening mechanism for ovarian cancer. An immediate Alliance 

priority is the development of a screening mechanism, as simple and accessible as the Pap smear or mammogram.

We urge those of you here today to make this a top priority, and to urge colleagues to do the same. Until such a

screening device is available, early stage ovarian cancer will continue to be missed too often and many thousands 

of women will needlessly continue to die.

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Despite the many new life saving therapies developed in recent years and the infusion of new funds designated for ovarian cancer research, much more research must be done to gain a better understanding of key 

aspects of this disease, to improve dramatically the survival rate. We urge that as the women’s health research 

agenda is set, the compelling needs of ovarian cancer be given top priority.

Executive Director

Virginia T. Ladd, R.T. American Autoimmune Related Diseases Association

Autoimmunity is a women’s health issue. Women with an autoimmune disease frequently experience physical and emotional problems as a result of delay in correctly diagnosing an autoimmune disease. Additionally,

autoimmunity must be understood as a category of diseases, like cancer. A powerful need exists to conduct 

collaborative research on autoimmunity, the common link to many chronic diseases which are currently treated, 

and studied, independently.

Autoimmunity is a Major Health Problem. Autoimmunity is a debilitating condition in which the immune 

system attacks the body’s own tissues or cells. Autoimmunity is the root cause of over 80 serious, chronic 

diseases, including lupus, rheumatoid arthritis, multiple sclerosis, Graves’ disease/hyperthyroidism and Type I 

diabetes. Autoimmune diseases afflict an estimated 50 million Americans at an annual cost of $86 billion.

Autoimmunity is a Major Women’s Health Problem. Autoimmune diseases represent the fourth largest cause 

of disability among women in the U.S., striking three times as many women as men. The gender disparity is 

even greater for many autoimmune diseases. 

Autoimmunity is known to have a genetic component, and tends to cluster in families as different diseases.

People with autoimmunity often experience more than one autoimmune disease. Because confusing, sometimes

intermittent symptoms of autoimmunity vary both among the different autoimmune diseases and within a particular disease, getting a proper diagnosis for an autoimmune disorder can prove as difficult for some women as 

living with the disease itself.

The physical and psychological toll of misdiagnosis and late diagnosis for sufferers of autoimmune diseases 

can be substantial. No early diagnosis means no early treatment, worsening the health burden that a patient must

bear. Late diagnosis is also devastating, as a physician may not take the patient’s complaints seriously, and the

patient may have to endure a long series of unsuccessful tests and procedures from a range of specialists 

before receiving a successful diagnosis. 

Need for Basic, Collaborative Research. Basic research on autoimmunity will yield information that benefits the

treatment and diagnosis of all autoimmune diseases and represents the most promising approach to finding a cure.

There has been no general focus on autoimmunity as the underlying cause of these related chronic conditions.
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Some progress has been made. Exciting breakthroughs in research focused on new treatments for autoimmune diseases, such as with oral tolerization, have shown promise for several autoimmune diseases across 

clinical categories and underscore the common link among the different diseases.

Conclusion. ORWH has the capability to improve our country’s approach to autoimmunity. Efforts to channel

additional resources to basic biomedical research on autoimmunity will encourage the coordination of currently

fractured research efforts. Such collaboration will also promote the increasingly supported view that autoimmune

diseases are connected by common threads. And research will concurrently increase awareness and knowledge 

of autoimmunity among the medical community and the public, thereby aiding early diagnosis and treatment.

AARDA urges ORWH to seize this timely opportunity to address one of the leading and most vexing health 

problems facing American women. 

Mary Lamielle National Center for Environmental Health Strategies, Inc.

The National Center for Environmental Health Strategies, Inc., based in Voorhees, New Jersey, is a national,

not-for-profit, membership organization fostering the development of creative solutions to environmental health

problems with a focus on indoor pollution, chemical sensitivities, and environmental disabilities. The Center has

become a preeminent source of public information, educational materials, technical support, and input on research

and to the Government on environmental illnesses including sick building syndrome, chemical sensitivities, Gulf

War Syndrome, and related disorders.

We have been the pathfinders in the area of multiple chemical sensitivities (MCS). Based on several government and university-based studies, the number of individuals reporting sensitivity to everyday chemical exposures 

is on the rise, with women reportedly outnumbering men. Little research has been done to help us understand 

the phenomenon, address the health issues for those who report chronic illness and disability, provide treatment

protocol, or protect public health.

Patients most frequently report an initiating event such as a pesticide application, new carpet installation,

remodeling activities, solvent exposures, inadequate ventilation, or poor air quality. Following this exposure event

the patient will find, over time, that she reacts to more and more, different substances and products at lower and

lower exposure levels. Clusters of symptoms will be triggered on a day-to-day basis upon exposure to a diverse

array of common substances and products including pesticides, perfumes, auto and diesel exhaust, tobacco smoke,

air fresheners, deodorizers, dry cleaning fluid, hair spray, and other personal products just to name a few. Those

patients who cannot remove themselves from such exposures will generally find that their health declines rapidly,

and that they experience significant levels of illness and disability.

In July 1987, the Board on Environmental Studies and Toxicology at the National Academy of Sciences held 

a workshop to examine indoor pollution and chemical sensitivity. Experts at this workshop issued an estimate that

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“approximately 15 percent of the U.S. population have an increased allergic sensitivity to chemicals commonly

found in household products, such as detergents, solvents, pesticides, metals and rubber, thus placing them at

increased risk to disease.” The consensus from the meeting was that further research is needed to examine the

extent of this public health problem and the role that indoor pollutants, particularly from consumer products, 

play in promoting chemical sensitivity. Despite this auspicious beginning, the first government-sponsored workshop on MCS was not held until 3 years later. It took directed Congressional funding and another 2 years until 

the Agency for Toxic Substances and Disease Registry created an expert panel and convened a neuroscience 

workshop in Baltimore. To date little research has taken place to illuminate this issue.

Meanwhile, industry, segments of the medical community, and insurance companies are among those groups

who remain the tremendous obstacles to investigating and acting on MCS. A research agenda to investigate MCS

and related disorders is long overdue. I would urge you to examine the compelling needs of those disabled by

MCS, and to assign the highest priority to this significant and growing public health problem. If the apparent rise

in MCS patients is accurate, progressive loss of tolerance for everyday chemical and environmental exposures may

have profound consequences for the public health and society.

Marian C. Limacher, M.D. American College of Cardiology

Coronary heart disease (CHD) is the leading cause of death in American women. While not comprehensively

studied over previous decades, information now exists about risk factors, diagnosis, management and prognosis for

women with CHD. Differences between men and women are evident in many aspects of the CHD spectrum of evaluation and outcomes. For some increases in mortality, differences have been shown to be related to increased levels

of other features that impart higher risk, including older age, more advanced disease and more concomitant diseases, rather than gender-specific factors. Some reports suggest bias in decisionmaking when diagnosing or treating

women. Much more information is needed to determine the sources of differences and the adjustments needed to

improve the outcome of women with CHD.

Topics recommended for further research include: assessing risk factor intervention (particularly diabetes); 

primary prevention of CHD with cholesterol lowering agents with consideration of the potential interaction with

hormone replacement therapy; programs to improve health behaviors, in general, and programs designed to reduce

teenage smoking and increase physical activity, in particular; treatments for obesity and their impact on CHD; 

algorithms for diagnostic testing; studies to assess optimal therapy for men and women to eliminate biases and 

produce evidence-based guidelines; studies on survival of myocardial infarction; assessing appropriate dosing 

of new agents for women and men; and studies to assess the impact on aging vs. gender on diagnostic and 

therapeutic decisions and in assessing outcome.
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Lisa Lindahl Epilepsy Foundation of America

The Epilepsy Foundation of America (EFA) is a national voluntary health agency representing the interests of

the over 2 million Americans with epilepsy. Ms. Lindahl is a member of the EFA Board of Directors and chairs the

Foundation’s Women and Epilepsy Initiative. EFA has a long-standing commitment to basic and clinical research

advocacy and has recently focused efforts on promoting more research on women’s health issues.

Over 1 million women in the United States have epilepsy. Seizures and exposure to anti-epileptic drugs 

(AEDs) may alter female reproductive function and may have a negative effect on pregnancy and reproductive

health. For instance, women with epilepsy are at greater risk for pregnancy complications, while fetal exposure 

to AEDs increases the risk of birth defects. Efficacy of hormonal contraceptives may be compromised by interactions with drugs to control seizures. Recent studies show that fertility is lowered and sexual dysfunction affects

nearly one-third of women with seizure disorders.

Recommendations for further research:

• Birth outcomes. Issues around teratogenic drugs and pregnancy must be explored to address the serious 

problems of infant mortality and birth defects; we currently do not know enough about the association

between folic acid and decreased risks of serious birth defects, or actual outcomes from folate use.

• Reproductive health. Incidence of reproductive endocrine disorders in women with epilepsy must be examined, including concerns about anovulatory cycles and polycystic ovarian disease; impact of this on general

health, such as cardiac functioning and other metabolic issues are poorly elucidated or understood.

• Family planning/contraception. Increased risk of contraceptive failure needs examination; need to understand if contraceptives affect seizure control.

• Hormone replacement therapy. Need findings to establish relative risk-benefits of HRT for women with epilepsy.

• Bone health. Poorly understood in women with epilepsy, especially with regard to usage of anti-epileptic drugs.

• Hormone-to-seizure/seizure-to-hormone relationships. Need to understand reasons for changes in seizures 

and seizure control at puberty, during the menstrual phases, and at menopause.

• Behavioral and psychosocial issues. Impact of epilepsy on factors of neuropsychological functioning 

and independent living must be examined more thoroughly, including learning, memory, depression, 

employment, and parenting, among others.

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Randall McCoy CareTrends Health Education and Research Institute

Osteoporosis is a major public health problem today and is certain to grow in the future. Osteoporosis occurs 

in 37 percent of the population of which one-third are men. In the 1990s, an estimated 2.5 million hip fractures, 

5 million vertebral fractures, and 375,000 deaths occur annually due to osteoporosis. This will increase as the

elderly population continues to grow. The risk of a 50-year-old white woman for a fracture related to osteoporosis is 30 to 40 percent.

In addition to being devastating to its victims’ quality of life, osteoporosis has a profound, negative economic

impact. The condition costs more than $20 billion per year, with projections of $60 billion by the year 2010. Costs

include treatment for fractures, acute-care hospitalization, and rehabilitation. Complications following fractures 

further add to the costs. A large percentage of persons with osteoporosis-related hip fractures are discharged from

the hospital to skilled long-term care facilities. Because many persons are being treated for osteoporosis, the 

majority of funding for treatment comes from publicly financed health care programs. The staggering economic 

and social cost of osteoporosis places a heavy burden on the health care system.

Osteoporosis can be detected early by a simple x-ray test known as a Dual Energy X-ray Absorptiometry

(DEXA) scan that is extremely accurate. Evaluation of bone mass of the hip, spine, and wrist early in life can 

predict who will develop osteoporosis later in life with a high degree of reliability. Identified individuals at high 

risk for osteoporosis can receive interventions which will delay or prevent osteoporosis development. Screening 

of young adults must be done to identify those persons requiring intensive intervention to prevent osteoporosis

complications in the future. 

Nutrition and exercise are major factors in the prevention of osteoporosis. Adequate calcium and vitamin D

intake in children and adolescents is necessary for increased bone mass. A significant body of research demonstrates that women who have received adequate nutrition, particularly calcium and vitamin D, have a lower rate 

of osteoporosis. Therefore, intensive nutrition education and intervention are mandatory and should contribute 

to osteoporosis prevention. Lifestyle is an additional factor in osteoporosis prevention. In children, a positive 

association exists between physical activity and bone mass affecting skeletal mass later in life. Weight bearing 

or strength and resistance training/exercise can also reduce bone loss in older women. Therefore, exercise 

education is essential to prevent osteoporosis.

In addition to behavioral modification, a number of effective pharmacologic agents are available to treat osteoporosis. The therapy of choice is hormone replacement therapy, specifically estrogen. At the menopause, estrogen

has been proven successful in maintaining bone mass, for the majority of women, for the duration of the therapy.

However, as soon as estrogen therapy is withdrawn, loss of bone mass will resume. In many patients, medications

from the bisphosphonate class will increase bone mass by 5 to 7 percent. Compliance with medication treatment 

is not reliable. While estrogen therapy has been the treatment of choice for osteoporosis, only 15 percent of women

who are prescribed estrogen continue to take the hormone 12 months after the initial prescription is filled. Very 

little data exists about the rate of compliance for other agents used for osteoporosis treatment. Further study is 

necessary to evaluate the compliance with medication regimens. 
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Currently, no ongoing, long-range program exists to determine bone mass in premenopausal women and, in

particular, female teens. Studies are required to determine the need for therapies to stabilize bone mass in young

women who may have seriously depleted skeletal mass. Dietary surveys in the U.S. report decreased calcium intake

in adolescent females at a time when their need for calcium is high. These factors contribute to low bone density as

women age, which leads to increased fractures. Similarly, little is known about the adolescent development of the

male skeleton and to what extent risk factors such as poor diet, lack of exercise, and smoking have on skeletal mass

in the general male population. Baseline data are needed on the prevalence of low bone mass in males between 

20 and 50 years of age and from 51 and beyond. 

Given the prevalence of the risk factors in the general population, osteoporosis is, and will continue to be, 

a greater public health problem than generally is recognized. We have been involved in a clinical trial of a drug

thought to be effective in the treatment of women with osteoporosis and established vertebral compression fractures. Approximately 4,000 women have been screened since mid-October 1996 in the northern Plains states. 

At several of the screening sites, nearly 70 percent of the women receiving DEXA scans have qualifying bone 

mass. Approximately two-thirds of that number have qualifying fractures and osteoporosis.

In the earliest recruiting efforts for the clinical trials, bone scans were offered to women of any age in order 

to heighten awareness of the study and to encourage younger women to bring to their mothers, aunts, and grandmothers to the osteoporosis screening. Although the number of premenopausal women scanned was small, the

results were alarming. We demonstrated that the number of women in the population with low bone density may 

be higher than originally thought, due to the prevalence of many risk factors such as excessive smoking, alcohol

consumption, lack of regular exercise, and poor diet. Given the diversity in the population being scanned, there is

great concern that the incidence of osteoporosis in the general population is much greater than current estimates. 

The status of bone mass and skeletal health in the U.S. must be addressed more vigorously. Saving billions of

dollars in health care costs is possible if a proactive approach to prevention and early treatment is taken. However,

data are insufficient to determine the magnitude of the problem in the population. In addition, little is known

about the impact of preventative measures taken by young adults which might drastically reduce the likelihood 

of developing osteoporosis and paying the high economic and human costs in their later years of life. Therefore, 

we propose a national, longitudinal osteoporosis project to identify persons at risk for the disease and provide

health education to decrease the prevalence of osteoporosis. The overall, long-term goal of our program is to 

provide screening and health education to the general public to decrease the prevalence of osteoporosis. The 

specific aims are to:

• Develop accurate epidemiological information on the number of men and women of various ages 

in the United States who have clinically significant low bone mass.

• Determine to what degree behaviors can be modified and how behavior modification impacts 

on skeletal health.

• Determine if educational intervention in young women will change behaviors and improve 

skeletal health in late adolescence.

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• Determine compliance rates in women who have been placed on bisphosphonates, calcitonin, 

and other therapeutic regimens.

• Evaluate the usefulness of biological markers in monitoring the study populations.

• Reduce costs to publicly funded health care programs. 

Details of the Longitudinal Osteoporosis Research Project are presented in the full version of our testimony.

Professor of Psychology (Neuroscience), Harvard Medical School

Director, Alcohol and Drug Abuse Research Center

Nancy K. Mello, Ph.D. McLean Hospital

Recommendations for Research on Drug Abuse and Alcoholism in Women

Drug and Alcohol Effects on Reproductive Function. Alcoholism and drug abuse are frequent problems among

young women, early in their reproductive years. A number of neuroendocrine abnormalities are associated with

chronic drug and alcohol abuse that may impair fertility and/or compromise neurobehavioral development of the

offspring. Neuroendocrine abnormalities in women are expressed clinically as disorders of the menstrual cycle, i.e.,

annovulation, luteal phase dysfunction, and amenorrhea. Disorders of prolactin regulation, expressed as hyperprolactinemia, sometimes associated with galactorrhea, are also observed. The risk for spontaneous abortion is a frequent concomitant of alcohol and cocaine abuse. Alcoholism is also implicated in early menopause, but the cocaine

epidemic is too recent to evaluate its effects on the menopause. Most drugs of abuse can disrupt the menstrual

cycle. Polydrug abuse probably exacerbates the severity of these disorders as well as complicating interpretation 

of the role of cocaine, opiates or alcohol per se. However, many menstrual cycle disorders have been replicated 

in animal models of drug and alcohol self-administration under controlled conditions. The possible mechanisms 

by which cocaine, opiates, and alcohol disrupt the menstrual cycle are unknown and have important implications

for women’s health.

Interactions Between Menstrual Cycle Phases, Abused Drugs, and Treatment Medications. In addition to the 

adverse effects of abused drugs on the menstrual cycle, hormonal changes across the menstrual cycle also can 

influence the effects of abused drugs. Recent evidence suggests that the hormonal profile associated with the 

follicular, peri-ovulatory and mid-luteal phases of the menstrual cycle may influence the reinforcing as well 

as the toxic effects of abused drugs. These interactions are poorly understood and may affect initiation as 

well as perpetuation of drug abuse. 

There is also increasing evidence that the efficacy of some therapeutic agents may vary as a function of menstrual cycle phase. It is important to evaluate the ways in which the hormonal milieu of each phase of the menstrual

cycle may modify the effectiveness of medications as a function of hormone-related changes in the pharmacokinetics and pharmacodynamics of the medications. Finally, treatment medications may also disrupt the menstrual
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cycle. Opioid antagonists that are effective in treating opioid abuse also may stimulate gonadotropin release and

enhance fertility. Preclinical and clinical studies should be conducted to address these important health issues. 

Substance Use After Menopause. In view of the trend towards an aging American population, and the relative

longevity of women in comparison to men, special attention should be paid to the impact of alcoholism and drug

abuse on the health of perimenopausal and postmenopausal women. Recent evidence that social drinking can

increase estradiol levels by over 300 percent in postmenopausal women on estrogen replacement therapy suggests

the importance of evaluating drug and alcohol effects in older women. Drug induced changes in estradiol could

alter the complex risk-benefit ratio of hormone replacement therapy in postmenopausal women. Moderate alcohol 

use could contribute to protection from osteoporosis and premature cardiac disease often ascribed to estrogen

replacement therapy and/or enhance the risk for adverse health consequences. Alcohol and drug effects on the

health of older women is an understudied area.

Immune Function and Vulnerability to AIDS: The Role of Drug-related Hormonal Changes. Cocaine administration

may enhance both risk for HIV infection and severity of progression of HIV as a function of needle-sharing, direct

immunosuppressive effects and hormonal factors. Cocaine stimulates the hypothalamic-pituitary-adrenal axis, and

pharmacokinetic analyses have revealed a very close temporal concordance between increases in plasma cocaine

levels and plasma ACTH levels in humans. In addition, cocaine administration causes a significant increase in plasma

cortisol levels following an antecedent increment in the pulsatile release of ACTH. Recent studies have revealed the

importance of glucocorticoids in modulating immune function in HIV infection. Development of medications for

the treatment of cocaine abuse and dependence should involve evaluation of medication effects upon the hypothalamic-pituitary-adrenal axis to determine the hormonal consequences of treatment. 

Virginia Miller, Ph.D. Women’s Health Care Council, Mayo Clinic

The Women’s Health Care Council is a group of 20 physicians and scientists appointed by the Board of Governors of the Mayo Clinic to address mechanisms to improve women’s health care through clinical practice, education

and research. The Mayo Clinic and Foundation is a private, multidisciplinary, integrative practice with three primary locations in Rochester, MN, Scottsdale, AZ, and Jacksonville, FL and regional practices in the upper Midwest.

Priorities for women’s health through the 21st century should encompass the entire scope of a woman’s health

experience including prevention, early detection, intervention, and rehabilitation programs. Several areas are identified in which the resources available at the Mayo Clinic could be used to advance women’s health. These are:

1. Translating outcomes from clinical trials to the community setting.

2. Applying innovative prognostic, predictive and early detection diagnostic procedures to appropriate populations for women at risk for cardiovascular disease, cancer, and osteoporosis.

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3. Translating knowledge from basic sciences to relevant populations of women through integrative, 

multidisciplinary approaches.

4. Understanding basic mechanisms of disease processes with an emphasis on cardiovascular disease,

ovarian cancer, and anabolic therapies for bone.

5. Establishing smoking cessation and other rehabilitation programs tailored to meet the unique 

needs of women.

Ann Mulligan DES Cancer Network

The DES Cancer Network is a national nonprofit consumer advocacy organization that addresses the special

needs of women who have had clear cell adenocarcinoma of the vagina or cervix — a cancer linked to prenatal exposure to the synthetic estrogen diethylstilbestrol or DES. The DES Cancer Network provides surviving clear cell cancer patients with ways to contact and support one another; to offer assistance and information to newly diagnosed

patients who are undergoing treatment; and, to support those women whose clear cell cancer is terminal.

DES daughters are at increased risk for a rare cancer of the vagina or cervix, called clear cell cancer. So far,

clear cell adenocarcinoma has been found in DES daughters between the ages of 7 and 42. Clear cell vaginal or 

cervical cancer, the “signature” cancer of DES, is linked to in utero exposure to DES. Typical treatment includes 

radical hysterectomy, vaginectomy, lymphadenectomy, and vaginal reconstruction. Radiation is often used with

surgery. The current estimate is that one in 1,000 DES daughters are at risk for developing clear cell cancer. It is

important that DES daughters and their physicians be aware that there is no specific age after which the risk for

clear cell cancer is over. At this time the upper age limit for the development of the cancer is unknown. 

Several issues related to DES exposure and clear cell cancer should be made a priority for research at NIH.

• What are the risks for DES daughters as they enter menopause?

• What are the benefits and risks of estrogen/hormone replacement therapy for women who were 

prenatally exposed to the synthetic estrogen diethylstilbestrol?

• Are DES daughters at increased risk of developing clear cell adenocarcinoma at perimenopause? 

Is there another incidence peak of clear cell cancer at menopause?

• Clear cell adenocarcinoma was known before DES in postmenopausal women. What might the 

experience of DES daughters be when they reach the age when clear cell had previously been 

diagnosed? Are we headed for an explosion of clear cell cancer cases?
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• What are the best treatments for clear cell adenocarcinoma? Is surgery, chemotherapy, or radiation 

most successful?

• What is the an effective treatment for recurrences of clear cell cancer?

Mary Lynn Newport, M.D. American Society for Surgery of the Hand

The American Society for Surgery of the Hand identified three areas in women’s musculoskeletal health that

need further investigation. These include the study of distal radius fractures (Colles’ fracture), carpal tunnel syndrome, and osteoarthritis of the basilar joint of the thumb.

Colles’ fractures comprise approximately 10 percent of all adult fractures. Women are affected seven times

more often than men. After fracture of the distal radius, the risk for fracture of the hip increases threefold, which 

has a nearly 25 percent mortality rate within 1 year of injury. Colles’ fractures clearly are not a benign entity when

considering the patient’s overall health and there is significant upper extremity and lifestyle morbidity after sustaining such a fracture. There has been significant interest in treatment of the distal radius fracture itself, but almost no

research in preventing these injuries or using them as a catalyst for treatment of the underlying osteoporosis and

prevention of hip fracture.

Carpal tunnel syndrome, or compression of the median nerve in the wrist, is another upper extremity condition which preferentially affects women, with nearly 11 percent of all women living to age 70 suffering from this

condition. There has been a great deal of research into treatment of the condition itself, especially the surgical

decompression of the carpal canal, but almost no research into the underlying pathophysiology of the condition 

in an effort to prevent its occurrence.

Osteoarthritis of the basilar joint of the thumb in effect compromises the function of the entire hand. Nearly 

50 percent of postmenopausal Caucasian women will suffer near complete destruction of the cartilage of this joint.

A number of surgical treatments have developed for this condition but no research is currently being conducted 

to discern the cause of this condition or how this condition might be prevented.

These are all areas that significantly impact women’s health, their family, and the economy. All deserve 

greater attention as we work to help prevent many of the conditions that today we can only incompletely treat.

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Gloria J. Nichols, B.S.P., M.Ed., Ph.D. and 

Catherine A. White, B.S.P., Ph.D. College of Pharmacy, The University of Georgia

New Priorities for Research on Women’s Health in the Pharmaceutical Sciences

1. Gender-related analysis of medications; specifically the pharmacokinetic differences in the absorption, 

distribution, metabolism, and elimination of drugs and changes that occur during pregnancy and different phases of a women’s life span.

2. Research on the considerations of the sociodemographic factors such as gender, age, race, 

socioeconomic status, ethnicity, and cultural background affecting quality-of-life measures and 

pharmacoeconomic studies in women and minorities.

3. Epidemiological research on disease patterns, health risk assessment profiles, and methodological 

developments in gender-related outcomes measurement. Health risk assessment focuses on the characteristics of the targeted population that are linked to behavioral and environmental risks, and the 

health consequences of exposure to those risks. Research is particularly needed to explore factors 

that lead to and result from exposure to adverse effects of drug entities as potential risks in women.

4. Research on the influence of hormonal factors on the course of specific diseases and disorders affecting

women, along with the utility of using hormonal strategies as potential hormonal agents in treatment 

and patient management.

5. Outcomes research studies that relate to the clinical manifestations, risk factors, disease course and 

response in such disorders as osteoporosis, osteoarthritis, and fragility. Studies are needed on the 

markers of prognosis and followup on recent progress on biologic and genetic markers along with 

therapeutic management decisions to the disease potential.

6. Ongoing research for new developments in AIDS research and drug development. This will include 

an overview of the epidemiology of the disease state and the outcomes research for evaluating effective 

drug therapy protocols; successful medical interventions, and optimal economic and therapeutic 

options for the practice setting.

7. Research studies on the risk and benefits of hormone replacement therapy and new developments 

in terms of humanistic, economic, and quality-of-life parameters. Cross sectional, longitudinal, retrospective and prospective studies are needed. Different populations at risk, compliance, and followup, 

and the presence of concomitant risk factors and duration of HRT should be considered.

8. Cardiovascular disease research in women should include more demonstration projects on management

strategies, including the use of group and educational programs for risk factor reduction, as well as indications for drug therapy and practice guidelines for hormone replacement therapy. Factors defining the

high-risk patient (utilization of standardized guidelines), assessing and identifying women at high risk, 

and guidelines for utilization of therapeutic options need to be clarified.
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9. Research that examines the physiologic and pathophysiological differences that are responsible for 

cardiovascular disease and altered drug responses that occur in minority populations and women.

10. Patient decisionmaking models and information systems, and computerized systems of on-line information services should be further developed, tested, and evaluated, for accuracy of information; their

impact on knowledge and confidence; and their usefulness in patient education and compliance in 

the management of drug therapy.

Nancy J. Norton, B.S. International Foundation for Functional Gastrointestinal Disorders

Functional Gastrointestinal Disorders have not been adequately addressed in the research and patient care

communities. Irritable bowel syndrome (IBS) is the most predominant of the functional gastrointestinal disorders.

Approximately 35 million Americans suffer from IBS. The symptoms of abdominal pain, bloating, constipation,

diarrhea, and fecal soiling affect people from all walks of life. The fact that 75 percent of sufferers are female makes

IBS a major issue in women’s health.

IBS accounts for 20 to 50 percent of referrals to gastroenterology clinics. An IBS sufferer will miss an average 

of 13.4 days of work annually. It is a multibillion dollar problem.

Because of the risk of unnecessary surgery, the potential for misdiagnosis, and the use of unneeded diagnostic

procedures, there is a pressing need to support education and research that will benefit both the public and the

medical community.

IBS is a chronic disorder and continued scientific investigation is needed to understand the precise mechanism. In addition, it is necessary to study the patient to find the proper treatment that reduces symptoms and

improves quality of life. A biopsychosocial understanding must be developed in order to advance behavioral 

and pharmacologic treatments.

Nancy L. Parsley, D.P.M. American Podiatric Medical Association

Podiatrists are keenly aware of the need for more research directed at foot ailments. Foot disorders represent 

a tremendous cost to the health care system. Foot pain and foot disorders not only drain vital health care dollars 

in a direct way, but their wider socioeconomic impact includes lost productivity as well as potential compromises 

to one’s quality of life. This presentation addresses a variety of issues related to foot health and the substantial 

need for further research. 

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First, diabetes is a chronic disease afflicting approximately 16 million people in the United States, half of 

whom are unaware they have the disease. It is the fourth leading cause of death by disease in the United States. 

An estimated 15 percent of those with diabetes will develop an ulceration on the foot during their lifetime, 

and 20 percent of those ulcerations will lead to amputations. Existing data suggests that amputation rates 

are higher in males than females, but anyone with the disease faces potentially devastating consequences.

Women with a history of diabetes, especially those who developed it at a young age, undergo menopause 

early, which increases their risk of cardiovascular disease. One suggestion for counteracting the effects of early

menopause is the development of a regular exercise program. The importance of proper foot care in adhering to 

a physical fitness program cannot be underestimated. We must study and understand better what the long-term

effects of exercise on the feet are, especially in the presence of complicating illnesses such as diabetes. Diabetes 

foot pathology exists as the most common diabetic complication requiring hospitalization with approximately 

70 percent of all diabetics experiencing some form of neuropathy. Greater concentration in the area of diabetes,

specifically involving the prevention of foot deformities and complications must be a research priority. 

Another area for focus involves the proper choice of footwear. The 1990 National Health Interview Survey 

concluded that foot problems were more commonly reported by females than males, and by Caucasians than

blacks. The survey results demonstrate just how prevalent foot disorders are. A prevalence-to-incidence ratio 

of 83 percent was reported for corns and calluses; for bunions and arthritis of the toes, the ratio was in the 

vicinity of 90 percent. Bunions were found to be five times as common among females as males and arthritis 

of the toes was reported twice as often by females versus males. Other deformities of the toes or joint were also

found to be twice as common among females as males. We need to explore how we account for these findings 

and how we address them. 

In 1992, the APMA commissioned a survey on public attitudes towards foot care. The results of the survey

revealed some disturbing trends. For instance, over half of the women interviewed admit to experiencing foot 

pain. Nearly one-third reported wearing shoes that are uncomfortable but look good. One-third of the women 

in the survey wore high heels despite the pain and the potential damage to their feet. 

What are the long-term effects of these attitudes and trends? Does the society in which we live and function

create unrealistic demands on women in their selection of appropriate footwear? To what degree does foot pain 

due to inappropriate shoe selection contribute to lost productivity on the job? Is foot pain compromising one’s

quality of life by preventing an individual from participating in a physical fitness program or desired social activities? To what extent might foot pain create undue stress that affects one’s mental health? We recognize a connection

between foot health and overall health status, but to what degree can improved foot health improve physical as 

well as mental health? These questions deserve consideration in assessing research needs and priorities. More

research would allow us to treat foot disorders more effectively while enhancing preventive efforts.

Another area specific to women’s health that deserves further investigation involves the effects of pregnancy 

on the feet. A study by Vullo, et al. found that lower extremity pain is more likely to be developed by pregnant 

and postpartum women compared to nulliparous women. Another study by Alvarez, et al. found that the mean 
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volume of the feet increases by 57.2 milliliters between early and late pregnancy and decreases by only 8.42 milliliters between late pregnancy and 8 weeks postpartum. These changes were attributed to retention of fluid 

or to an increase in soft tissues. A better understanding of and appreciation for the effects of pregnancy on 

one’s feet requires further study. 

Consider also the role of women in sports. Women have consistently expanded their participation in sports at

every level, not only at the collegiate and professional levels. As young children and adolescents, girls are encouraged to be participate in sports-related activities. Women are demonstrating athletic prowess in areas previously

considered to be the sole domain of men. The long-term effects of these changes in attitudes and patterns of 

physical fitness are yet to be sufficiently explored. 

Available evidence indicates an inverse association between physical activity and chronic diseases. The feet 

factor prominently in many forms of exercise and maintaining healthy feet is imperative to maintaining good

health. But while the benefits of exercise are obvious, more research is needed to determine the effects of a 

variety of factors on the risks of exercise-related injuries as well as how to make more judicious choices on 

how best to achieve the benefits of exercise while preventing injuries.

Rheumatoid arthritis (RA) exists as another important area for investigation and research. Not only is the 

disease not well understood, but the prevalence in females is between 2:1 and 4:1 over males, depending upon 

the source. RA is incurable and its progression can lead to debilitating deformities which substantially affect 

a patient’s quality of life. When the feet are involved, the presentation is most often in a symmetrical pattern. 

Additional research is needed to better understand the effects of RA in general and on the feet, in particular. 

Considerations with an aging population deserve attention. Mobility is a vital ingredient of the independence that older people, in particular, cherish. Therefore, dedication of research dollars and research efforts 

in maintaining foot health should be a priority. 

The APMA believes ORWH can offer important leadership in the research arena. Between 1994 and 1996, 

only 10 percent of the total dollars dedicated to podiatric medical research came from the Federal Government. 

The APMA and the podiatric medical colleges contributed a combined amount of almost 50 percent of the total

research dollars. The wide disparity in research funding cannot continue if we are to address the specific needs 

of women in today’s health care environment. If we are to fulfill our role in keeping America walking and maintaining foot health, we need to see noticeable increases in research dollars dedicated to these purposes. An 

investment of this type is guaranteed to have far-reaching and long-lasting benefits far into the future.

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Kenneth A. Perkins, Ph.D. University of Pittsburgh School of Medicine

Need for New Directions in Research on Smoking Cessation in Women

The prevalence of tobacco smoking has declined gradually in the U.S. since publication of the first Surgeon

General’s Report on Smoking in 1964. However, this decline in smoking has not been equal across all smokers 

but has been attenuated in women compared with men. There has been evidence for several decades that women 

are less likely than men to successfully quit smoking. Some large-scale smoking cessation trials, especially those

involving nicotine replacement therapy, suggest that women are less likely than men to initiate quitting and more

likely to relapse if they do quit. Various explanations for the poorer success of smoking cessation efforts in women

have been offered, including reinforcement in women of the influence of smoking on body weight or food intake

control, reduced availability of social support for cessation in women, and greater impact of advertising on promoting smoking in women.

One possible explanation that has not received attention is that men and women may differ in the extent to

which they smoke for nicotine reinforcement, as opposed to smoking for other, non-nicotine factors (e.g., other

sensory effects of smoke inhalation, conditioned responses to smoke stimuli, secondary social reinforcement).

Recent research suggests that: nicotine self-administration (i.e., reinforcement) is less robust in women; women 

may reduce their smoking to a lesser degree following nicotine pre-loading, and women may be less sensitive 

to subjective/mood effects of nicotine. In contrast, women may be more responsive to non-nicotine stimuli of

smoking. These findings are consistent with other research indicating that women are less able than men to 

detect interoceptive stimuli (physiological changes) as well as some findings that women may be less sensitive 

to other drugs, such as cocaine.

Since many current smoking cessation efforts focus on nicotine replacement therapy (gum, patch, etc.), 

smokers who smoke less for nicotine reinforcement would be less likely to obtain therapeutic benefits from 

nicotine replacement strategies. Perhaps not surprising, a review of clinical research studies indicates that women

are less likely than men to be successful in quitting smoking as a result of receiving nicotine replacement. Therefore, the most widely-used strategies for aiding smokers to quit are less effective in women, and new interventions

that adequately address the consequences of quitting in women are needed.

In summary, based on current research, it appears that, relative to men, smoking behavior of women is reinforced less by nicotine intake and more by other, non-nicotine factors. These sex differences have important clinical

implications; nicotine replacement may warrant a less important role in smoking cessation while interventions to

counter non-nicotine aspects of smoking may need to be emphasized. Greater research on sex differences in nicotine effects and in new directions for smoking cessation treatment in women is warranted.
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Jann Primus, Ph.D. Associate Professor of Biology, Spelman College

It is no secret that the U.S. educational enterprise is seriously underperforming. Distressing indicators include 

an alarmingly low level of scientific and technological literacy in the general population; a projected shortage of

well-equipped scientists, mathematicians, and engineers; and severe inequities in the access of minorities and

women to science and medical professional fields. 

Data reveal that in 1973, minorities comprised only 8.3 percent of employed scientists and engineers. Two

decades later, this figure had increased to only 17.5 percent. Analyses of rates of participation of blacks and Hispanics confirm a picture of severe underrepresentation in science and mathematics at all levels of our system 

of education as well as in the health professions. 

In contrast to national trends, historically black, minority, and women’s institutions have been the forerunner

in recruiting, retaining, and successfully graduating women and minorities in the sciences at the baccalaureate level

and have been successful in encouraging these underrepresented populations to enter professional schools and

Ph.D. programs. These schools have in common a strong tradition of community. Community is what propels

many minority graduates and graduates of women’s colleges to successful careers. These settings warm the chilly 

climate for women and minorities so often noted at all levels of education in this country. Private liberal arts

women colleges have been especially productive of women science and mathematics graduates and of women 

graduates who subsequently earn a doctorate in science or mathematics. Indeed, these colleges produce a 

higher percentage of women science graduates than any other nonspecialized category of institution. 

The high concentration of black science and mathematics graduates in the historically black colleges and 

universities stands in sharp contrast to the almost complete absence of black graduates in science and mathematics

at the vast majority of the nation’s colleges and universities — this despite the fact that nearly all colleges and 

universities have black students.

The existence of effective learning communities in HBCUs is an important factor in the success of students 

in science, but it is not the only factor. In HBCUs, professors demand serious study and hard work, and they

believe that deficiencies in background can be overcome. Promising students are encouraged to engage in research

projects. As a result of high expectations by the faculty, students see success in science and mathematics as attainable, and therefore they can achieve.

The success of HBCUs and women’s institutions in successfully nurturing, preparing, and graduating skilled

scientists and health professionals is especially evident at Spelman College. Spelman’s success in producing dynamic African-American women is most profoundly represented in the sciences. Before it was an issue of national

concern, Spelman was building a strong science program with the goal of answering the needs of our nation 

and its business and educational communities. 

Research and research training are an integral part of the Spelman College science program. Faculty at HBCUs

are active researchers. We attempt to instill in our students a love and respect for research and investigation. As

Spelman prepares for the new millennium, we do so with a strong appreciation of the role science and technology

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will play in determining our nations ability to compete and our responsibility to educate students who are equipped with the skills to meet these challenges. If Spelman College typifies the atmosphere of excellence that resonates 

on the campuses of our nation’s HBCUs, then we can not underestimate the critical role HBCUs, minority and

women’s institutions will continue to play in providing our nation with dynamic future leaders in science and 

the health professions.

In sum, minorities and women increasingly emerge as a vital part of the human resources that our country

depends upon to ensure its continued growth and well being. The AAMC has established a goal of enrolling 

3,000 underrepresented minority students in U.S. medical schools by the year 2000. Current trends indicate that 

we will fail to achieve that goal. NIH, however, with a $12.7 billion annual budget, can lead the way in the federal

sector to reverse this trend. We need additional programs targeted toward enhancing the capacity of HBCUs,

minority, and women’s institutions. We want to branch out into RO1 level research. We want to become meaningful partners, principal investigators, in the more than $12 billion in research that NIH funds each year 

through its 21 institutes. And we want to be in earnest conversation with NIH and other federal agencies 

to help set the nation’s scientific research policy agenda.

In this way, we can be assured that populations who can most benefit — African Americans, minorities and

women — are included in clinical trials, have options for experimental drugs, and that faculty from minority 

institutions are significantly involved in performing the investigations. We can also be assured that diseases 

and ailments that so disproportionately affect minorities and women — diabetes, hypertension, teenage pregnancy, low-birthweight babies, heart attacks, strokes, sickle cell anemia, kidney failure — are given adequate 

attention and funding.

Bladder Health Council of the

Bette A. Rank and Thomas M. Bruckman American Foundation for Urologic Disease

The mission of the Bladder Health Council (BHC) of the American Foundation for Urologic Disease (AFUD) 

is to provide research, education, and awareness to the general public, patients, and health care providers nationally about bladder diseases and conditions. These include urinary incontinence, urinary tract infections, interstitial

cystitis, and bladder cancer.

Urinary incontinence afflicts approximately 13 million Americans over 65, of whom 80 percent are women.

The condition affects people of all ages and social and economic levels. Approximately 800,000 elder Americans

living at home are beset severely enough to limit daily activities and become socially isolated. Urinary incontinence 

is one of the three major reasons for admittance to nursing homes. The economic impact of urinary incontinence

among persons over the age of 65, including direct costs attributable to routine care and adverse consequences, 

and indirect costs incurred by the patient, spouse, or caregiver who loses the potential to earn wages elsewhere,

totals $27.8 billion, or $3,941 per person.
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A study on “Women and Incontinence” by Yankelovich Partners published in Bladder Health Week

found that:

• A majority of women wait at least 1 year before discussing their condition with relatives, friends, 

or their physician.

• Most are hesitant to talk about incontinence, they are too embarrassed.

• Many curtail daily activities such as going to the store, taking walks, going on trips, and visiting friends.

• Generally urinary incontinence is accepted as a part of growing older.

• Numerous women surveyed stated that they were unhappy with their current treatment and were 

willing to try other options.

• Women were not satisfied with the care provided by their physician and would be willing to 

change physicians.

Better education for, research on, and treatment of women with urinary incontinence, especially 

at an earlier age, could lead to improved quality of life and ultimately lower health care costs.

Urinary tract infections (UTIs) are the number one urologic condition requiring approximately 1.6 million 

hospitalizations and 10 million physician visits each year, for a total cost of $4.4 billion. UTIs are an annoying

problem. One in five women will visit their doctor at least once each year for relief from a UTI. Twenty-five percent of women who experience one infection will develop recurrent UTIs and 5 percent of these are infections

caused by the same organism that caused the first infection. Young girls around 5 years of age may get a UTI; 

girls as they become sexually active may develop UTIs; and pregnant women can develop pyelonephritis during 

their third trimester. More than 20 percent of women over the age of 65 will experience asymptomatic bacteriuria 

and need to be carefully monitored. Bacteria in the urine can cause infection and inflammation of the bladder. 

If the bacteria travel upward from the bladder and reach the kidneys, a kidney infection may develop. Kidney 

infections are less common, but often more serious than bladder infections.

As many as one-half million people in the United States may suffer from interstitial cystitis (IC). Ninety 

percent of IC sufferers are women and the average age of onset is 40, with 25 percent of the cases under 

30 years of age.

IC is a chronic inflammation of the bladder. The symptoms are pain and pressure in the bladder, urethra, 

and pelvic areas, as well as increased urinary urgency and frequency. People with IC experience urgency and 

frequency of urination. They suffer with immense pain in the bladder, lower abdomen, and urethra. The pain 

experienced has been described as feeling like paper cuts, razor blades, or acid in the bladder.

Cigarette smokers have an increased risk of developing bladder cancer. Exposure to certain chemicals in 

the workplace has also been associated with an increased risk. When found and treated in the early stages, 

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even cancerous bladder tumors are not likely to spread and are not likely to be life threatening.

We encourage and support research and education of bladder diseases for women. Together we can make 

a difference toward improving quality of life for millions of women.

Vicki Ratner, M.D. Interstitial Cystitis Association

Interstitial cystitis (IC) is a chronic inflammatory bladder condition that affects approximately 450,000 people 

in the U.S., 90 percent of whom are women. Its cause is unknown and, at present, no treatments are uniformly

effective. The symptoms are similar to an acute urinary tract infection, but urine cultures are negative and the symptoms do not respond to antibiotics. IC symptoms can vary from mild to severe and unrelenting pain, urgency and

frequency of urination — up to 60 or more times in 24 hours. Although IC is not a fatal disease, suicides occur

every year because of inadequate pain management.

Although IC was first described early in the 20th century, virtually nothing was done before 1994 to adequately

address IC in terms of diagnosis, treatment or research. Only in the last ten years has IC been removed from the

psychosomatic chapter in Campbell’s Urology, the standard urologic textbook. IC was considered, and still is considered by some urologists as an “hysterical female condition.” Unfortunately, this blatantly incorrect label still

haunts IC victims with the sufferer taking on average 41/2 years to get a correct diagnosis and often having 

to see an average of five physicians before IC is diagnosed. 

IC symptoms are varied and not uniformly present in all IC sufferers. The severity of the pain, frequency, 

and urgency associated with IC can vary from reasonably manageable to unbearable, making it hard to classify 

as well as diagnose. No specific marker or test has been developed for IC, and it is considered largely a diagnosis 

of exclusion.

Because of its relentless demands on the body, IC can cause dramatic changes in the lives of people who 

suffer from it, making it difficult to maintain a job, making travel impossible, severely disrupting sleep, and 

making sexual intercourse extremely painful (many women abstain).

Since the founding of the Interstitial Cystitis Association (ICA) in 1984, much progress has been made 

in helping to create public awareness for the disease but much remains to be done.

1. Epidemiologic studies must be continued.

2. Basic science research, including identifying inflammatory mediators; etiology of IC; neuroinflammatory pathways in IC; pathology; endocrinological, hormonal and immunological aspects of IC.

3. Clinical trials of promising drugs.
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4. Further analysis of the IC database, a 6-year project which will be completed in spring, 1998.

5. Developing better educational resources and outreach programs to educate patients and members 

of the medical community. Encouraging researchers to work in this area and establishing research 

fellowships in this area.

The American Academy of Orthopaedic Surgeons

Sally A. Rudicel, M.D. The American Orthopaedic Foot and Ankle Society

The Orthopaedic Health of Women: Foot and Ankle Issues

Foot and ankle complaints are a common source of pain and disability in the United States. It is estimated 

that 43 million people in this country have foot complaints yearly. Fifteen million of these people will eventually

seek medical help, and the majority of these people will be women.

Forefoot pain is a very common complaint in all age groups. In this country, however, problems of the forefoot occur in women seven to eight times more commonly than men. In a study of 356 healthy women between

the ages of 20 to 60, a stunning 80 percent complained of foot pain. This same study found that 88 percent of

these women were wearing shoes too small for their feet, and that 76 percent of these women had some foot deformity. The most common forefoot problems are bunions, bunionettes, hammer toes and neuromas, all of which

occur disproportionately in women. These forefoot problems are a cause of pain and disability. As the deformities

progress, surgery is often necessary. An estimated 75 percent of forefoot surgery in this country is necessary because

of constrictive shoe wear. In 1995, approximately 285,000 bunionectomies, 300,000 hammertoes, 80,000 neuromas and 130,000 bunionettes were surgically corrected in the United States. If 75 percent of these procedures were

caused by constricting shoewear, the estimated surgical cost for forefoot problems is $2 billion dollars. If time off

from work is included, another 1.5 billion dollars in expenses is added. These figures are staggering and do not even

address the morbidity to the patients suffering from these problems. All of this for high fashion footwear.

The American Orthopaedic Foot and Ankle Society and its Council on Women’s Footwear has made major

efforts to publicize this information and educate the public, the shoe retailers, and the shoe manufacturers. Consumers must be educated about this debilitating health problem. We also need to investigate more vigorous early

preventative measures and look more critically at the benefits of surgery. 

Education of appropriate shoe wear needs to begin in childhood, since we know that shoes have an effect on

foot health. Education of parents as well as children about shoes is necessary. We also need further studies about

changing shoe trends and the effects on the feet in the long term. In addition, some businesses have dress codes

and requirements for women’s shoes. We need to stress the health risk this imposes and work toward a change 

of such policies.

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At the opposite end of the age spectrum, Carol Frey, M.D. has done some investigative work on the relationship of shoe wear to falls in the elderly. While a tie shoe is a safer shoe, Dr. Frey has found that even some athletic

shoes may be a cause of falls because of large lugs which wrap around the toe area of running shoes. Also, outer

soles which are wearing down, even on appropriate tie shoes, may cause a problem. More effort in exploring this

source of injury in the rapidly expanding elderly population may bring huge benefits both in the health of the

elderly and in better use of financial resources.

Rheumatoid arthritis is another entity with a predilection toward women. Women are affected three times 

more often than men. About 17 percent of cases of rheumatoid arthritis begin in the foot and the majority of

patients will have foot problems during the course of their disease. Again, education and earlier intervention 

may prevent or lessen the formation of these severe deformities. More investigative work on the primary treatment of the disease may also prove helpful.

When the foot hurts, the entire body hurts, and activity is severely restricted. Foot pains and deformities 

are a common finding in all age groups as our studies show. Forefoot problems in particular, affect women seven 

to eight times more frequently than men. We need to look further into the causes of these problems, search for 

prevention and educate our population at an earlier age. The Office of Research on Women’s Health can help 

us in the AAOS and AOFAS to play a leadership role in this important aspect of health.

Rosalie Sagraves, Pharm.D., F.C.C.P. American Pharmaceutical Association

APhA submits the following recommendations for specific areas in which the Office of Research on 

Women’s Health can have a major impact.

Gender Differences in Drug Delivery. ORWH should work with (1) the FDA in implementing the latter’s guidelines to ensure that women are included proportionately in future clinical studies, and that gender analysis 

be as complete as possible for labeling of commercially available products; (2) NIH to ensure that basic and 

clinical pharmacokinetic/pharmacodynamic studies are carried out. Regarding vitamins, pharmacokinetic/

pharmacodynamic proposals should examine possible gender differences.

Women as Care Givers. Women are the primary care givers for their families. The workshop should end with

recommendations to provide the tools women need to fulfill this function adequately. I applaud the FDA for identifying prescription medication use as an important women’s health issue, and for taking the initiative to involve

pharmacists and pharmacy students in educating women about their medicines and how to use them.

“Real-world” Research. Research recommended by ORWH could provide solid evidence that the cost to society 

of noncompliance and drug misadventure can be sharply decreased if pharmacy services are property structured 

and supported. APhA has created a Practice-Based Research Network (PBRN) of pharmacy practitioners who have

the skills and interest to perform research studies at their practice site under the aegis of Principal Investigators
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who may be either physicians or pharmaceutical scientists. Pharmaceutical manufacturers are exploring with APhA

the possibility of using the PBRN in a variety of Phase IV studies. Recommendations from this workshop should

take note that health professionals other than physicians are able to provide effective care in their respective areas of

knowledge, while continuing to recognize that the physician leads the team of well-trained health care professionals.

The issue of information exchange between professionals to smooth the continuum of care, particularly in light 

of emerging technologies, is an excellent example of an area for additional research.

Population-based Care. Recommendations should focus on the usefulness of population-based studies for 

reasons other than reducing costs. Managed care organizations in particular must be encouraged to share their 

databases with researchers to make these studies possible.

Self Care. The development of guidelines to help the consumer judge the quality and reliability of available

information should be one outcome of your work.

Cost-effectiveness. Research on the fastest growing group of health care users — the oldest old, who use the 

most resources on a per capita basis as they near the end of their lives — should be emphasized. Focusing research 

on pharmacoeconomic issues clearly would do much more than merely cut costs. Outcomes and quality of life

would be enhanced as well.

Charlotte (Barney) Sanborne, Ph.D. Texas Woman’s University

Although wellness has been emphasized during the past 10 years, statistics show that women are choosing 

not to participate in a wellness lifestyle. ORWH postulates that inactivity and harmful behaviors lead females 

to be more vulnerable to diseases, to experience more severe maladies than men, and to be impacted by health 

problems that are unique to women. In fact, women can significantly reduce the risk of both cardiovascular 

disease and osteoporosis with regular physical activity and proper nutrition. Despite this information, approximately 40 percent of American adults lead a sedentary lifestyle. These patterns begin in childhood and are 

especially prevalent in females. Early onset of obesity (by age 6) relates to an increased chance of obesity as 

an adult. Furthermore, the psychosocial ramifications, such as being ostracized by peers, may contribute to 

an overweight child’s low self esteem and poor body image.

Although principles for a wellness lifestyle have been established, involving people in the process of participating in healthy lifestyles is a completely different concern. Early detection and prevention health strategies are the

keys to avoiding a lifetime of medical treatments and financial burdens. For success, this process must focus on

prevention and be multifaceted, ongoing, include all ages, and remove significant barriers to health care resources.

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Historically, the medical model emphasizes diagnosis and treatment over the larger picture of health maintenance throughout the life span. While this attitude is presently in a state of transition, it is still apparent in 

the health care policies and systems in the United States. Such a narrow perspective of health, coupled with the

financial rewards and career advancement that may be associated with successful solutions to medical problems,

invariably leads to lack of multidisciplinary collaboration.

We propose an interdisciplinary approach integrating primary and specialty care as the best way for medicine

to focus on women as whole people. An interdisciplinary focus includes psychosocial factors as well as physical 

and biological factors. Research related to the health of women should encompass a more comprehensive design

which includes a broad, carefully planned assessment of the influence of culture, other psychosocial factors, and

the environment in which that community functions. Such designs should focus upon the community’s potential

(i.e., capacity-building factors). Further investigation should explore the mechanisms and realities of truly crossing

disciplines, not simply collaborating across subspecialties within a discipline. True multidisciplinary research will

bring together professionals involved in all levels of care, from prevention to diagnosis to treatment to education,

to insure a whole person exploration of women’s health.

Another specific research area that needs to be addressed is the impact of public policy on women’s health. 

An example is the Welfare Reform Act of 1996 in which resources have been limited in an effort to decrease

unwanted pregnancy. Research is needed to examine the impact of public policy on the health of not only the

mother but also the far reaching implications on the fetus, baby, and child.

Barbara Seaman National Women’s Health Network

Consumer Participation in Government-funded Research

There is a worldwide movement, gaining momentum, to include greater consumer participation in the 

concept, design, execution, and (perhaps) analysis of medical research, especially where taxpayer funding is

involved. As an editorial by Alessanda Liberati (Mario Negri Institute, Milan, Italy) in the British Medical 

Journal, August 31, 1997 observes:

“The quality and relevance of much clinical research falls short of patients’ needs....Even among progressive 

scientists and health professionals, a paternalistic attitude still prevails. They do not believe that patients 

and consumers can improve the decisionmaking process.....But successful efforts to shift the balance are 

becoming a reality, even in difficult areas such as oncology.”

I will briefly review the philosophies, ethics, and practical issues brought forward by advocates in these 

discussions, and provide the case history of a dispute between the National Women’s Health Network and 

a past Director of NIH, where, as it turned out, our consumer perspective was the more accurate.
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National Association for the Advancement of Women in Science (NAAWS)

Diane K. Seay Girls and Mentors Manifesting Achievement (GAMMA) Project

The National Association for the Advancement of Women in Science (NAAWS) is a student organization 

chartered at the University of New Mexico (UNM). The organization provides an arena for scientists to share 

their work and the dynamics of career, school and family. Gloria Sarto, M.D., Ph.D., Professor, Department of 

Obstetrics and Gynecology, and Andrea Allan, Ph.D., Assistant Professor, Department of Neuroscience, UNM, 

and Ellen Goldberg, Ph.D., President, the Santa Fe Institute, are our advisors.

A review of the literature substantiated our realization that confidence and an interest in science is best fostered 

at an early age. Consequently, in spring 1995, the Girls and Mentors Manifesting Achievement (GAMMA) project

was initiated. UNM women science students volunteered to mentor 5th and 7th grade rural school girls in small

groups, generating and answering questions which follow the steps of scientific inquiry. Girls were selected from

Los Lunas, New Mexico, a district that reflects the state of New Mexico in ethnicity. Intervention and control

groups were set up. Initially no female 5th graders agreed to participate stating that science was “boring” and “for

boys.” At that point, it was determined that intervention should include younger girls, and a tiered mentoring system for 3rd, 5th and 7th graders was devised. At the conclusion of each year, students visit research laboratories 

of women scientists at UNM. A closing ceremony gives girls the opportunity to discuss their projects in front of

peers, mentors, and supporters from UNM.

The GAMMA project would like to make the following observations:

1. Rural school girls need to be instructed in science by individuals who themselves have an interest 

in math and science. All students should be encouraged to think about scientific ideas and concepts 

in a manner which facilitates their teaching someone else.

2. Rural school girls need not only access to improved electronic methods for learning, but also, training 

in the use of these methods by individuals who are themselves comfortable with their capabilities.

3. Overall, awareness is heightened by such intervention methods regardless of whether the girls eventually

take more science and math classes or choose math or science careers. Better methods to measure effectiveness of mentoring interventions need to be developed. 

4. Rural school girls need increased exposure to women in science. We must continue to increase public

awareness of women in science. 

5. To generate an active rather than a passive interest in science and health issues for their future, 

rural school girls must be challenged to think and ask questions, to develop critical thought 

processes and perspective.

NAAWS would like to propose that women Ph.D. graduates in science be given the opportunity to teach science

in elementary, middle, and high schools in rural areas and to receive credit toward student loans just as physicians

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and nurses who choose to work in rural areas do. Additionally, course credit could be given for graduate students

to teach science in rural schools. In these ways an excitement for scientific inquiry would be fostered and maintained in the rural school setting. Finally, we would like to challenge every woman scientist to acknowledge the

influential part she plays in the lives of girls and women she encounters. Your example and encouragement make 

a difference.

Wesley Segawa Emory University School of Nursing

The Malama Community Prenatal Care program, in Hilo, Hawaii, was developed as the focus of an NIH-NINRfunded research demonstration project (1990-1995) with Dr. Dyanne Affonso from Emory University in Atlanta,

Georgia as principal investigator. The program aim was to deliver prenatal care to rural Hawaiian women living in

the Hilo-Puna district on the Island of Hawaii and was expanded to two additional sites on Oahu in 1995. Originally titled “Malama Na Wahine Hapai,” or Caring for Pregnant Women, this program was designed to be complementary to standard obstetrical care already available in each community and targeted Native Hawaiian, Filipino,

and Japanese women who were identified as being at higher risk for delivering low-birthweight infants. Program

mechanisms included: the establishment of a Neighborhood Women’s Health Watch involving ethnic and cultural

healers or elders; use of “mobile health stations”; organization of prenatal and postpartum services in collaboration with State of Hawaii, Department of Health public health nurses; and multiple community partnerships 

with local businesses, men’s service organizations, and ethnic organizations such as the Ke Ola Mamo-Native

Hawaiian agency. Mr. Segawa has been an active member of the Hilo community advisory board associated 

with the Malama program for the past 7 years.

Amanda Sherman DES Action USA

DES Action USA is a national nonprofit organization representing an estimated 10 million mothers, daughters,

and sons exposed to the drug, diethylstilbestrol (DES). DES Action USA provides education and support to those

exposed to DES, to increase public awareness about DES so that individuals can discover if they are exposed, and

to educate medical professionals so they can provide knowledgeable services to DES-exposed people. We also seek

to keep public attention on the story of DES as a reminder of the need for vigilance in regard to health care practices.

Eight years ago we at DES Action were alarmed to hear about the impending cutoff of funding for DES

research at the National Cancer Institute. Some of the comments which circulated included the sentiment that 

DES-related cancer affects a very small number of women, a finite population. We also heard that while cancer 

of the vagina or cervix is certainly a tragic diagnosis, the DES experience represented an anomaly of history, 

with few applications for the larger society.
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We were disheartened, though not entirely surprised, to hear this line of reasoning. We realized that DES

Action had to accelerate our work and include a campaign to raise awareness about the following points. One, 

that DES exposure has resulted in many disastrous health outcomes, some still under investigation, in addition 

to cancer. These outcomes have affected many more women and men than DES-related cancer. And two, that 

the DES experience contains essential lessons relevant to the entire population in terms of the particular hazards 

of fetal exposure to estrogen and the powerful potential of endocrine disrupting chemicals. After all, those who

have been exposed to DES have been the “canaries in the coal mine” for a number of very important health 

problems now coming to the fore.

With this in mind, DES Action launched a campaign that eventually not only restored and increased NCI 

funding, but also expanded research to include for the first time DES mothers and DES sons. In addition, the 

NCI has also broadened the scope of their inquiry to look at many other adverse health effects besides DES-related

cancer. We now seek to answer many outstanding questions, such as the possible effect of DES on such bodily 

systems as the skeletal and immune system, and on the grandchildren of the women who were exposed to DES.

Dean for Faculty Affairs

Eleanor G. Shore, M.D., M.P.H. Harvard Medical School

Program to Increase Representation of Women at all Ranks in Academic Medicine

One year ago, as Dean for Faculty Affairs at Harvard Medical School, I submitted public testimony about 

a new program to provide fellowship support for junior faculty at the most vulnerable point in their academic

careers, i.e., when professional and personal responsibilities conflict. I documented the lack of adequate representation of women at the higher academic ranks both at Harvard Medical School and nationally. Today I would 

like to give you a 1-year followup regarding the early effects of this program on the junior faculty who were 

recipients of these fellowships. Private funding from alumni/ae, friends, hospital departments, affiliated institutions, and women faculty was secured to provide partial support for ten junior faculty members each year for 

5 years. The $25,000 awards are intended to buy protected time in which the recipients can do research, 

prepare grant proposals, write papers, or develop a new curriculum. Or, if they are laboratory scientists, they 

can purchase the time of a research assistant. Men as well as women, may apply if they can demonstrate 

similar levels of conflicting personal responsibilities and obstacles to their academic work. 

As of this fall [1997], ten junior faculty have completed their fellowships, and 11 more have begun theirs. 

More than 136 applications were submitted this year for the second round of fellowships. Each recipient is 

asked to complete a report at the end of the year’s work.

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At a meeting in October 1997, three fellowship recipients appeared on a panel to discuss in more detail the

effects of their fellowships on their academic careers. The most compelling feature of their individual accounts was

their description of the leverage the fellowship awards had produced. Department heads regarded their academic

aspirations more seriously, protected time for academic activities was extended beyond the year of the actual fellowship, new collaborations materialized, and more departmental support was forthcoming for their research. 

We have been particularly pleased to see that there has been a spin-off effect from this effort. A separately

funded set of fellowships for basic scientists in the Faculty of Medicine at Harvard was announced with a particular emphasis on women applicants. Of the seven $50,000 fellowships offered in June 1997, four were awarded 

to women. Similarly, at an affiliated hospital in Boston, three fellowships were awarded to women with academic

promise and these same obstacles to their academic careers. 

It is our view that it is unconscionable to allow talented women (and men) to wither on the academic vine

when a modest amount of support could maintain their academic careers and preserve their capacity to contribute 

to the research and teaching that are absolutely vital to the future of medicine.

While these fellowships have already had a leverage effect for the recipients, they touch only a small fraction 

of the women and men who need help at this particular phase of their careers. The same problem is certainly

occurring in academic medical centers all over the country. A nationally funded, competitive fellowship program

that acknowledges this time-limited but serious problem when promising academic careers may be stifled without

temporary support for academic activities, would go a long way toward strengthening the talent pool for future

medical research and teaching. It would also help to diversify the senior faculty ranks by preventing the loss of

junior women faculty who are well trained and motivated but temporarily in need of assistance to overcome the

very real pressures created by the need to teach, do research, prepare manuscripts, submit grant proposals, and

take care of patients at the same time they are beginning to assume greater family and other personal responsibilities. The country can not afford to lose this talent.

Amanda Spitler American College of Rheumatology

The American College of Rheumatology is an organization of physicians, health professionals and scientists 

that serves its members through programs of education, research and advocacy that foster excellence in the care 

of people with arthritis, rheumatic and musculoskeletal diseases. Many of these diseases — including rheumatoid

arthritis, systemic lupus erythematosus, scleroderma, and Sjörgen’s syndrome, as well as osteoarthritis and osteoporosis, affect women disproportionately compared to men. The reasons for this disparity are not well understood, but there is evidence that the reasons are not just hormonal, but may reflect gender differences at the

genome level via control of gene expression. Our statement outlines the state of knowledge and future priorities in these women’s health areas.
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Osteoarthritis and rheumatoid arthritis, the most prevalent forms of arthritis, range from mild to severe and

can cause pain, stiffness and tenderness in and around the joint. Research on the effects of certain antibiotics, particularly doxycyline, on the progression of osteoarthritis is an area of continued focus. Advancements in research 

on rheumatoid arthritis have also been made through the identification of the genes involved in its onset.

Lupus, an inflammatory, autoimmune disease characterized by excessive production of antibodies directed

against the body’s own tissue, affects women approximately nine times more often than men and strikes during 

their reproductive years. Research into the cause of lupus has focused primarily on the genetic susceptibility 

of individuals. Recent studies indicate that more than one gene may be involved in conferring susceptibility 

to lupus, emphasizing the complexity inherent in identifying the genetic basis of the disease.

Scleroderma is characterized by inflammation and excessive accumulation of the structural protein collagen,

which leads to thickening or hardening of tissue, affecting women four times more often than men. In animal 

models, researchers have discovered a new cleavage site on the collagen molecule which may be an avenue for 

further development.

Osteoporosis, characterized by low bone mass, has recently come to the forefront of women’s health due to the

disproportionate occurrence of the disease in women compared to men. Unlike the aforementioned diseases, osteoporosis is a disease which is entirely preventable. Adequate calcium consumption, weight-bearing exercise, and an

overall healthy lifestyle are a few ways in which this disease can be prevented. Perhaps the most significant ally in

the fight against this disease is estrogen replacement therapy. Significant cost savings due to the fracturesparing effect of hormone replacement therapy have been documented.

The ACR continues to support the efforts of ORWH in contributing to the NIH women’s health 

research agenda. 

Donna E. Stewart, M.D., D.Psych. The Toronto Hospital, Ontario Cancer Institute

Women’s Health Program at the University of Toronto

The Toronto Hospital, Ontario Cancer Institute, (TTH, OCI) Women’s Health Program focuses on seven 

priority areas: women and cancer, cardiovascular disease, neurosciences, organ transplantation, mental health/

eating disorders, and reproductive health. The program emphasizes research, education, and health care delivery

and policy to adult women. The Joint Oncology Program with the Ontario Cancer Institute and Princess Margaret

Hospital has added special strength to programs in cancer prevention, screening, diagnosis, treatment, and survivorship in women. 

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In 1996 the Women’s Health Program at the University of Toronto obtained over $9 million dollars in research

grants supporting studies in women’s health. Research projects range from basic biological sciences to clinical projects including the context of women’s health, decisional science, psychosocial behaviour, and quality-of-life concerns.

Our Informed Medical Decision Group in Women’s Health with a core team from clinical epidemiology, health

psychology, neurosciences, women’s health, pharmacology, health administration, sociology, nursing, bioethics,

obstetrics and gynecology, surgery, family medicine, internal medicine, anaesthesia, and oncology is central to our

work. This group participates in quality-of-life studies, cost-effectiveness studies, the effects of drugs in pregnancy

and lactation, drug side effects, health psychology, information needs, decisional sciences, choice and compliance,

education, and postmenopausal health studies. 

Current research grants involve women and cardiovascular disease and study gender differences in symptoms,

presentation time, treatments and outcomes in tertiary and community hospitals. Cancer research involves gender

differences in cancer information, decisional preferences, and quality of life. Studies in transplantation look at equal

access to transplantation by women and whether women choose organ transplantation for the same reasons and

frequency as men. Our neurosciences research includes projects on epilepsy in women and differences in cognition

and choice. Autoimmune disease research covers the accelerated pace of arteriosclerotic disease in women with

lupus erythematosis. Mental health research includes studies of depression, anxiety, eating disorders, and psychotropic drugs in women. Reproductive sciences research includes post menopausal health and decisional determinants of prevention and treatment, advanced reproductive technology, and psychosocial screening for pregnant

women at risk for adverse postpartum outcomes. The Women’s Health Program’s information needs and concerns

surveys, and decision studies have resulted in consultations to a number of local, national, and international groups. 

Equally important to the Women’s Health Program is educating health care professionals and policy makers.

The Women’s Health Symposia Community Education Series was inaugurated to address identified needs of public

health education and consumer motivated research projects in women’s health. The symposia have resulted in ten

currently ongoing research projects. Improved clinical care and teaching in women’s health are additional outcomes. 

We have also been active in health provider curriculum reform for women’s health including participation 

in the National Academy for Women’s Health Medical Education, the American Association for Medical Colleges 

initiative on professional development for women and numerous international, and national presentations on

women’s health to professional audiences.

It is our belief that through consumer and professional education about women’s health, women and their

health care providers will become more knowledgeable and responsive to women’s special needs. Research in

women’s health will further inform us of women’s gender differences, preferences, and best practices. Our informed

decisionmaking group is central to the delivery of health information to women and advocacy for them to participate in their desired degree of informed medical decisionmaking. 
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Deborah Studen-Pavlovich, D.M.D. American Association of Dental Schools

The American Association of Dental Schools (AADS) has a strong interest in promoting the advancement of

women in the field of dental research, and identifying and representing women’s issues is a priority for the association. Unlike the training of medical doctors, whose research training is a post-residency endeavor, financial disincentives as well as current legislation limiting research award programs make it difficult for many dental school

graduates to pursue doctoral programs. In addition, medical research training programs are funded by a variety of

sources, whereas the National Institute of Dental Research is the only predominant funding source that supports

training for oral health research.

These problems faced by all dentists in pursuing research training are compounded for female dentists, especially since universities are the prime area for dental research and training. Although an increase in female enrollment in advanced dental programs is occurring, there is still evidence that women who are involved in oral health

research are underrepresented in dental school faculties. Compared to other professions such as law and medicine,

dental schools have a noticeably smaller percentage of professors at various levels who are women. 

The AADS recommends several initiatives to provide for qualified female researchers in academic dentistry.

These initiatives include programs which: 

1. establish mentoring programs linking high schools to universities; 

2. expand fellowship programs beyond basic research to include more clinical areas of oral health research; 

3. increase the number of positions in specific training and research programs to accommodate the 

increasing pool of women dental graduates; 

4. expand short-term research opportunities to simulate interest in research careers; 

5. develop research grants for other advanced dental education programs beyond oral and maxillofacial

surgery and oral pathology; and 

6. provide supplemental research opportunities to women who must often interrupt their careers for 

family care responsibilities, especially as these women re-enter dentistry and wish to continue their

research careers.

These initiatives will not only help more women contribute to advances in dentistry through research, 

but will also contribute to better oral health for all Americans.

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Laura Lowe Tosi, M.D. American Academy of Orthopaedic Surgeons

Nearly 39 million people visited physicians for musculoskeletal conditions in 1995, of which almost 21 million

patients were women. Orthopaedic surgeons see a large number of these patients. It is the hope of the American

Academy of Orthopaedic Surgeons that this testimony will help the Office of Research on Women’s Health accomplish its mission of increasing awareness of the importance of women’s health, the nature of women’s health issues,

and the need for more research.

This testimony addresses what is known, the gaps in knowledge, and suggested future research directions

about four conditions (prominent both by virtue of their prevalence and cost to society) that occur predominantly 

in women. Among the conditions seen most frequently in women are arthritis, osteoporosis, and sports injuries.

Although not as prevalent as these three, frozen shoulder syndrome remains one of the most common, yet least

understood conditions affecting shoulder mobility. Much information is known about these conditions, nonetheless, even more remains to be uncovered.

Further research on etiology, pathogenesis, diagnostic techniques, and treatment regimens will assist musculoskeletal care providers in providing the best possible care for their patients, both female and male.

The Paget Foundation for Paget’s Disease 

Charlene Waldman of Bone and Related Disorders

The Paget Foundation for Paget’s Disease of Bone and Related Disorders is a voluntary health agency which 

provides information and programs for consumers and medical professionals for a number of bone disorders

involving abnormal bone resorption. One of the disorders addressed by the foundation is primary hyperparathyroidism, a hormonal problem which occurs when one or more of the parathyroid glands produce too much

parathyroid hormone. When this happens, the blood calcium becomes elevated. Bones may lose calcium, and 

too much calcium may be excreted by the kidneys.

In the U.S. population, 28 out of every 100,000 people can be expected to develop hyperparathyroidism each

year. Women outnumber men by three to one, and the frequency of the condition increases with age. Among women

over age 60, new cases can be as high as 2 out of every 1,000 women or 2,000 out of every 1,000,000 annually.

A major complication of primary hyperparathyroidism is the weakening of bones due to loss of calcium, 

sometimes causing osteoporosis. Other complications include depression and kidney stones.

At present, the only known cure for this condition is surgical removal of the affected gland(s). Estrogen 

therapy may reduce some of the effects of the disease in women who have gone through menopause, but this 

treatment will not directly control the glandular overactivity. There are also some experimental drugs to control 

the elevated calcium but these are not approved for routine use.
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Clinical studies are needed to acquire information about the natural history of the disease, the incidence of

fracture, and other complications including the neuropsychiatric manifestations. Also, greater insight into the 

relationship between the hyperparathyroid process and postmenopausal bone loss is essential. Information is also

needed on the course of patients who undergo parathyroid surgery as well as those who are followed conservatively. Additional studies will help to refine more clearly currently accepted guidelines for surgery versus medical

management for primary hyperparathyroidism. Also, research is needed to study possible medical therapies.

Joanne A.P. Wilson, M.D., F.A.C.P. American Gastroentrological Association

I represent the American Gastroenterological Association (AGA), a professional society of 8,900 clinicians,

researchers, and educators specializing in digestive diseases, and the Gastroenterology Women’s Coalition (GWC),

which is composed of women gastroenterologists from the AGA, American Society for Gastrointestinal Endoscopy,

American Society for the Study of Liver Disease, and the American College of Gastroenterology. The GWC’s mission

is to promote the awareness of the impact of digestive diseases on women and to enhance research funding into the

causes, treatment, and cures of these disorders. The GWC also works to promote gender diversity in the fields of

gastroenterology and hepatology.

Gender-based differences have been well documented in a number of digestive diseases which affect Americans. I wish to highlight the advances that have been made in the study of these disorders, and the areas that need

further investigation and should be included in the women’s health agenda for the 21st century.

Colorectal Cancer. Colorectal cancer is the second deadliest cancer in the United States. It is the third leading

cause of cancer death in women. In the coming year over 130,000 Americans will be diagnosed with colorectal

cancer and over 50,000 will die from this disease. The risk for 65-year-old women for colon cancer is approximately the same as that of breast cancer. However, research dollars for investigation of this preventable cancer 

pale in comparison to that allotted for breast cancer research.

The AGA and a consortium of GI societies and governmental agencies have developed national practice 

guidelines for the screening and surveillance of colorectal cancer. The expert panels concluded that screening 

and surveillance regimens beginning at age 50 for average risk individuals and at a younger age for persons at

increased risk are effective in preventing and curing colon cancer. This year Congress passed important legislation providing for Medicare coverage of colon cancer screening in the elderly. Our next task is to educate the 

public, especially women, physicians, and health care providers on the benefits of screening and surveillance 

and to encourage further research into epidemiological, prevention, and intervention strategies, including 

dietary and hormone replacement therapy.

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Irritable Bowel Syndrome and Functional Bowel Disorders. Irritable bowel syndrome is twice as common in

women as in men and affects up to 15 percent of the U.S. population. These disorders, which are associated 

with abdominal pain and bowel dysfunction, result in increased health care utilization and decreased work 

productivity and are one of the leading causes of absenteeism. Recent research has improved our understanding of these disorders. Additional research is needed into the effects of:

• menstrual cycle,

• predictors of chronicity,

• other etiologic factors that may contribute to the development of this disorder, and

• effective treatment and development of more specific agents for the treatment of these disorders.

Helicobacter Pylori and the Upper GI Tract. Great strides have been made in the treatment of peptic ulcer disease

with the discovery of Helicobacter pylori. However, further research is needed to fashion more effective treatment

and to explore gender differences with respect to the role of this organism in the development of gastric cancer.

NSAIDs and Peptic Ulcer Disease. Non-steroidal antiinflammatory drugs (NSAIDs) are also important causes 

of peptic ulcer disease in women. Further education of both women and men to the potential of side effects of 

these medications is needed.

Gallstone Disease. Gallstone disease is a major problem affecting approximately 10 percent of the U.S. population and is twice as common in women as in men. This increased prevalence is attributable to estrogens and progesterones on the liver and gallbladder, especially during pregnancy. Little is known of a natural history of gallstones

in women as most of the histologic studies done in this country were performed in men. We need further research

into the development and prevention of gallstones in women and outcome of treatment with regard to incidence,

mortality and health costs.

Liver Disease. Disorders of the liver, such as primary biliary cirrhosis and other liver diseases, require further

research particularly on the effects of estrogens on the immune system and metabolic research.

Many research questions regarding GI disorders in women deserve further study. I have highlighted the 

ones which are most notable for increased incidence in women, high health cost utilization and expenditures, 

and high morbidity and mortality.

I wish to emphasize the need for enhancing biomedical career opportunities for women. The GI societies and

the AGA have supported career-mentoring in women and minorities. We encourage NIH to expand its support 

for mentoring and to encourage special academic tracks for women. We encourage academic institutions to adjust

tenure and promotion policies to accommodate leaves of absence that may be necessary for parenting. I encourage

institutions to fund programs to prepare women for senior administrative positions which will be so necessary as

we advance into the 21st century.
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Association of Women’s Health

Ruth York, Ph.D., R.N., F.A.A.N. Obstetric and Neonatal Nurses

The Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN), an organization of 22,000

nurses and others committed to excellence in nursing practice for the health and health care of women and newborns, has a long-standing commitment to women’s health research and the use of that research in practice. 

As an organization, we support and conduct research endeavors that strengthen the scientific basis of nursing

practice. We believe that research which seeks to improve the health of women across their life span, such as prevention of adolescent pregnancy, improved reproductive health, and enhancement of postmenopausal well being, 

is necessary and vitally important.

Research in women’s health does not provide information about how the health of women in today’s society

can be optimized. In addition, inadequate access to primary preventive services, underrepresentation of women 

in clinical research trials, underutilization of research findings to support clinical practice and lack of information

on the economic ramifications of women’s health outcomes research are critical issues for all research conducted in

women’s health. Within the context of these issues research on adolescent pregnancy, violence against women, 

substance abuse, breast cancer, menopause, cardiovascular disease, are but some of the health problems that 

remain vital concerns to women, their families, and society.

• Research has had little impact on providing solutions to reducing the incidence of adolescent pregnancy. 

Clearly, unique and innovative research approaches are needed to address the issues of adolescent pregnancy and its multiple, negative-associated sequela.

• In the area of violence against women, delineating the factors which impede or facilitate women to resolve 

the abuse situation is critical and may vary for women of different ages, races, and ethnic groups. In the area 

of substance abuse, research has shown that the effect is gender dependent. Therefore, comprehensive investigations are needed to develop and test appropriate, cost-effective management strategies for substance-abusing

women and their families.

• For the women diagnosed with breast cancer, research on treatment, sociocultural and behavioral concerns 

is essential. With advent of genetic testing, new and important areas for research will expand. 

• Insufficient research has been conducted on clinical management of women’s postmenopausal health concerns,

such as use of hormone replacement therapy and other potential health altering intervention modalities. 

• It has generally been assumed that management of cardiovascular diseases is the same for men as it is for

women. However, new evidence strongly suggests that interventions which are gender specific must be 

developed and tested.

AWHONN supports research that focuses on health promotion and maintenance, as well as disease prevention,

throughout women’s life span; adequate representation of women in future studies of health problems; research on

health problems that primarily affect women; and research on diseases with social origins with emphasis on development of gender-specific interventions.

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY
APPendix

DoubleTree Hotel Philadelphia

Philadelphia, Pennsylvania

September 25-27, 1996

AGENDA

WEDNESDAY, SEPTEMBER 25, 1996

PREMEETING ACTIVITIES: A PUBLIC HEARING

1:00-6:00 p.m. Public Testimony: The Women’s Health Research Agenda for the 21st Century

Vivian W. Pinn, M.D.

Associate Director for Research on Women’s Health, NIH, and Director, ORWH

1. Continuing or Emerging Gaps in Knowledge About Women’s Health

Task Force 

2. Successful Models for the Recruitment, Retention, Re-entry, and/or Advancement 

of Women in Biomedical Careers

Task Force 

6:00-7:30 p.m. Meeting with Task Force/Ad Hoc Working Group and Workshop Cochairs

Dr. Pinn

THURSDAY, SEPTEMBER 26, 1996

WORKSHOP DAY 1

Continuing and Emerging Scientific Issues for Women’s Health Research: 

Influence of Sex and Gender on Health

8:30 a.m. Workshop Welcoming Remarks and Overall Charge for the Conference

Dr. Pinn

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BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH

FOR THE 21 S T CENTURY
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Introduction of Conference Cochairs

Donna Dean, Ph.D.

Acting Chief, Referral and Review Branch, Division of Research Grants, NIH

Marianne Legato, M.D.

Associate Professor of Clinical Medicine, Columbia University

College of Physicians and Surgeons

Introduction of Host Institution Cochairs

Jeane Ann Grisso, M.D., M.Sc.

University of Pennsylvania, School of Medicine

Bonita Falkner, M.D.

Professor of Medicine and Pediatrics, Institute for Women’s Health

Allegheny University of the Health Sciences

Overview: Beyond Hunt Valley: Research on Women’s Health for the 21st Century

Charge to Working Groups 

Dr. Pinn

Task Force Cochairs

Logistical Instructions

Local Cochairs

Dr. Grisso

Dr. Falkner

9:45 a.m. Break

10:00 a.m. Concurrent Breakout Working Groups

Consider overarching health and issues of aging, chronic disease, the molecular bases for 

male/female differences in disease, behavioral and prevention strategies, risk factors for 

major health issues, gender, diversity, and the environmental impact on women’s health.

GROUP 1. CARDIOVASCULAR DISEASE AND VASCULAR BIOLOGY

The role of gender in angiogenesis, vascular remodeling, cell structure/function, 

thrombosis. Linkage with sex hormones and cardiovascular disease, diabetes, stroke, 

obesity, and role of nutrition.

GROUP 2. NEUROSCIENCE AND BEHAVIOR

The role of sex/gender in neurodevelopment, CNS structure/function. Linkage with 

sex hormones and cognitive function, perimenopausal cognition, aging cognition, 

eating disorders, and the impact of environmental exposures in women.

GROUP 3. IMMUNOLOGY, GROWTH, AND DEVELOPMENT

The role of sex/gender in inflammation and immune response. Linkage with sex 

hormones, aging, arthritis, and lupus. Role of sex, gender, signaling, and growth factors.
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GROUP 4. INFECTIOUS DISEASES AND EMERGING INFECTIONS

Role of sex/gender in the etiology, transmission, course, and outcomes of infectious 

diseases, including HIV, STDs, and others involving emerging pathogens, with a focus 

on improved prevention, diagnosis, and treatment for women.

GROUP 5. MENTAL AND ADDICTIVE DISORDERS

The role of sex/gender in the etiology, course, comorbidity, and outcomes of mental 

and addictive disorders, including sex hormones, genes, gene-environment interactions, 

gender-related risk behaviors, depression, and eating disorders.

GROUP 6. REPRODUCTIVE HEALTH

Research to address life-span issues including research on contraception (development, 

use, and post marketing evaluation), (IOM report), as well as the influence of contraceptive choice on infertility, STDs, (IOM report), acute and chronic conditions, and lifestyle. 

Consider particularly implantation, maternal issues, prevention, diagnosis, treatment 

of pregnancy complications and embryo or fetal loss and reducing morbidity from myoma,

endometriosis, abnormal uterine bleeding, uterine prolapse, and other benign gynecologic 

diseases. Address hormone replacement therapy, menarche, menopause, postmenopausal

issues, and cultural, ethnic, socioeconomic, and behavioral issues.

GROUP 7. CANCER

Address basic science, genetics, gender differences, and environmental factors contributing 

to mortality in breast, lung, colon, and gynecological cancers to understand the malignant

processes and to lead to improved prevention, diagnosis, and treatment. Consider female 

populations that bear a disproportionate burden of cancer incidence and mortality. Ethical, 

legal, and social implications of new technologies including screening and genetic testing.

Noon Lunch Remarks 

Jo Ivey Boufford, M.D.

Principal Deputy Assistant Secretary for Health

U.S. Department of Health and Human Services

1:30 p.m. Working Groups (continued)

3:30 p.m. Break

3:45 p.m. Plenary Keynote Speaker

Nancy Wexler, Ph.D.

Higgins Professor of Neuropsychology, Columbia University

4:15 p.m. Working Group Summary Reports

5:30 p.m. Adjourn

6:00 p.m. Reception
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FRIDAY, SEPTEMBER 27, 1996

WORKSHOP DAY 2

Continuing and Emerging Scientific Issues for Women’s Health Research: 

Research Strategies

8:30 a.m. Kickoff Speaker

Ruth L. Kirschstein, M.D.

Deputy Director, NIH

9:00 a.m. Plenary Session 

Models for the Conduct of Research on Women’s Health: Research Strategies and Methods

9:30 a.m. Charge to the Working Groups: The Future for Women’s Health Research

9:45 a.m. Break

10:00 a.m. Concurrent Breakout Working Groups

Consider overarching issues of life span, aging, prevention, diversity, and collaborative and 

multidisciplinary approaches. The impact of managed care, informatics, and what is ready 

for testing and commercial application should be considered as well as socioeconomic, cultural, 

and sex/gender factors in the identification of unique barriers for:

A. RESEARCH DESIGNS

1. Multidisciplinary Perspectives: How can synergy between scientific disciplines be 

achieved through a multidisciplinary perspective that incorporates biomedical, 

psychosocial, and socioeconomic approaches to women’s health research?

2. Cultural Diversity: How can diverse communities of women participate actively 

in helping set research priorities, participate in clinical studies, and, most importantly, benefit from the implementation of the outcomes. Communities refer to 

different levels of social organization, from families to neighborhoods, and to other

forms of community. How can cultural and socioeconomic factors be differentiated

from race and incorporated into the study of health and disease of women? Culture

refers to shared values and beliefs about the world. Epidemiologic analyses of health

outcomes in diverse populations should also be addressed.

3. Gender: What are the best ways of conceptualizing and studying similarities and 

differences between males and females? As examples, effects might be due to genetics, sex-related hormones, gender role socialization, and disparities in power and

status in society between women and men.
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B. HEALTH IMPACT AND HEALTH OUTCOMES

1. Biotechnical Advances: How can advances in biotechnology be incorporated into 

clinical care and health professional education programs for women’s health, 

including prevention, screening, and treatment? The role of gender in access to 

care, diagnostic and therapeutic interventions, and patient-provider communication should be considered. What are the ethical, legal, and social issues? How 

can the diverse community of women benefit from state-of-the-art research?

2. Gender Differences: How can knowledge of gender differences across the life span 

be applied to preventative interventions? Consideration should be given to what 

constitutes successful life course transitions (entrance to school, adolescence, 

entrance to parenthood, widowhood).

C. WOMEN IN BIOMEDICAL CAREERS: ISSUES OF IMPORTANCE FOR 

YOUNG INVESTIGATORS

Positive ways to advance women’s careers through training, leadership opportunities, and mentorship. What are successful examples of recruitment, retention, 

re-entry, and advancement?

12:15 p.m. Break

12:30 p.m. Lunch

Keynote Speaker

Karen Davis, Ph.D.

President, The Commonwealth Fund

1:45 p.m. Plenary (Working Group Reports)

3:30 p.m. Closing Remarks and Adjournment

Dr. Pinn
PHILADELPHIA, PENNSYLVANIA

SEPTEMBER 25-27, 1996

PARTICIPANTS

Dyanne Affonso, Ph.D., F.A.A.N.

Dean and Professor

Nell Hodgson Woodruff School of Nursing

Emory University

Atlanta, Georgia 

Graciela Alarcon, M.D., M.P.H.

Professor of Medicine

Associate Director Arthritis Center University 

of Alabama

Birmingham, Alabama 

Judith Albert, M.D.

Assistant Professor

Department of Obstetrics, Gynecology, and 

Reproductive Sciences

University of Pittsburgh School of Medicine

Division of Reproduction Endocrinology

Magee-Womens Hospital

Pittsburgh, Pennsylvania 

Nancy Alexander, Ph.D.

Chief, Contraceptive Development Branch

Center for Population Research

National Institute of Child Health and 

Human Development 

National Institutes of Health

Bethesda, Maryland 

Ann Anderson, Ph.D.

Acting Dean

Tulane University School of Public Health 

and Tropical Medicine

New Orleans, Louisiana 

Karen Antman, M.D.

Professor of Medicine, Columbia University

Chief, Division of Medical Oncology

Columbia Presbyterian Comprehensive Cancer Center

New York, New York 

Deborah Armstrong, M.D.

Assistant Professor of Oncology

Johns Hopkins Hospital

Medical Oncology

Baltimore, Maryland 

Constance Atwell, Ph.D.

Associate Director, Extramural Activities

National Institute of Neurological Disorders and Stroke

National Institutes of Health

Bethesda, Maryland 

Byllye Avery

Founder

Associate Director for Government Affairs

National Black Women’s Health Project

Swarthmore, Pennsylvania 

Anne R. Bavier, M.N., F.A.A.N.

Deputy Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Consuelo Beck-Sagué, M.D.

Associate Director for Minority and Women’s Health

National Centers for Infectious Diseases

Centers for Disease Control and Prevention

Atlanta, Georgia 

Michelle Berlin, M.D., M.P.H.

Assistant Professor of Obstetrics and Gynecology, 

and Epidemiology

Center for Clinical Epidemiology and Biostatistics

University of Pennsylvania

Philadelphia, Pennsylvania 

Janet Bickel

Assistant Vice President for Institutional 

Planning and Development

Association of American Medical Colleges

Washington, District of Columbia 

Stephanie Bird, Ph.D.

Special Assistant to the Provost

Massachusetts Institute of Technology

Cambridge, Massachusetts 

Beyond Hunt Valley: 

Research on Women’s Health for the 21ST Century

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VOLUME 2

Mary Blehar, Ph.D.

Chief, Mood, Anxiety, and Personality 

Disorders Research Branch

Division of Clinical and Treatment Research

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland 

Sandra Bloom, M.D.

Executive Director, The Sanctuary, Friends Hospital

President-Elect, International Society for 

Traumatic Stress Studies

Quakertown, Pennsylvania 

Mark Boyd, Ph.D.

Department of Oncology

Allegheny University of the Health Sciences 

Center City

Philadelphia, Pennsylvania 

Patricia Braly, M.D.

Professor

Chief, Section of Obstetrics and Gynecology

Louisiana State University Medical Center

New Orleans, Louisiana 

Edward Brandt, Jr., M.D., Ph.D.

Regents Professor and Director

Center for Health Policy

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 

Otis Brawley, M.D.

Director

Office of Special Populations

National Cancer Institute

National Institutes of Health

Rockville, Maryland 

Isadore Brodesky, M.D.

Chair, Hematology/Oncology

Allegheny University of the Health Sciences 

Center City

Philadelphia, Pennsylvania 

Sandra Brooks, M.D.

Director, Division of Gynecologic Oncology

Department of Obstetrics and Gynecology

University of Maryland School of Medicine

Baltimore, Maryland 

Carol Brown, M.D.

Clinical Assistant Surgeon, Gynecological Service

Department of Surgery

Memorial Sloan-Kettering Cancer Center

New York, New York 

Zora Brown

Founder and Chair

Breast Cancer Resource Committee

Washington, District of Columbia 

George Bryan, M.D.

Dean Emeritus, School of Medicine

The University of Texas Medical Branch

Galveston, Texas 

Virginia Cain, Ph.D.

Special Assistant to the Director 

Office of Behavioral and Social Sciences Research 

Office of the Director

National Institutes of Health

Bethesda, Maryland 

Richard Cannon III, M.D.

Deputy Chief for Clinical Services

Cardiology Branch

National Heart, Lung, and Blood Institute 

National Institutes of Health

Bethesda, Maryland 

Arthur Caplan, Ph.D.

Director, Center for Bioethics

University of Pennsylvania

Philadelphia, Pennsylvania 

Wendy Chavkin, M.D., M.P.H.

Editor-in-Chief

Journal of the American Medical Women’s Association

Beth Israel Medical Center

Chemical Dependency Institute

American Medical Women’s Association, Inc.

New York, New York 

Mary T. Chunko, M.A.

Information Development Specialist

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Marilee Comfort, Ph.D., M.P.H.

Research Director

Family Center

Thomas Jefferson University

Philadelphia, Pennsylvania 

Helen Coons, Ph.D.

Director of Evaluation

Health Federation of Philadelphia

Philadelphia, Pennsylvania 
480

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

George Counts, M.D.

Director, Office of Research on Minority 

and Women’s Health

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland 

Terri Damstra, Ph.D.

Associate Director for Science Coordination 

National Institute of Environmental Health Sciences 

National Institutes of Health 

Research Triangle Park, North Carolina 

Alice Dan, Ph.D.

Professor

Center for Research on Women and Gender

University of Illinois at Chicago

Chicago, Illinois 

Karen Davis, Ph.D.

President

The Commonwealth Fund

New York, New York

Donna Dean, Ph.D.

Acting Chief

Referral and Review Branch

Division of Research Grants

National Institutes of Health

Bethesda, Maryland

Betty Diamond, M.D.

Professor

Department of Microbiology and Immunology, 

and Medicine

Albert Einstein College of Medicine

Bronx, New York 

Kay Dickersin, Ph.D.

Associate Professor

Department of Epidemiology

University of Maryland at Baltimore

Baltimore, Maryland 

Leah Dickstein, M.D.

Professor

Department of Psychiatry and Behavioral Sciences

School of Medicine

University of Louisville

Louisville, Kentucky 

Catherine Didion

Executive Director

Association for Women in Science

Washington, District of Columbia

Andrea Dunaif, M.D.

Senior Director, Diabetes Medical Research

Parke-Davis Medical Research

Parke-Davis Building 79-2

Morris Plains, New Jersey 

Jacqueline Dunbar-Jacob, Ph.D., R.N., F.A.A.N.

Professor and Director

Center for Research and Chronic Disorders

School of Nursing

University of Pittsburgh

Pittsburgh, Pennsylvania 

Carola Eisenberg, M.D.

Lecturer in Psychiatry

Dean for Student Affairs (Retired)

Harvard Medical School

Cambridge, Massachusetts 

Tom Eng, V.M.D., M.P.H.

Senior Program Officer 

Institute of Medicine

Washington, District of Columbia

Donald Faber, Ph.D.

Chair, Anatomy

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Bonita Falkner, M.D.

Professor of Medicine and Pediatrics

Institute for Women’s Health 

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Loretta Finnegan, M.D. 

Director, Women’s Health Initiative

National Institutes of Health

Bethesda, Maryland 

Leslie Ford, M.D.

Associate Director 

Early Detection and Community Oncology Program

Division of Cancer Prevention and Control

National Cancer Institute

National Institutes of Health

Bethesda, Maryland 

Michael Fordis, M.D.

Director

Office of Education

National Institutes of Health

Bethesda, Maryland
481

VOLUME 2

Patricia Fraser, M.D., M.P.H.

Assistant Professor of Medicine

Director, Pediatric Rheumatology

Brigham and Women’s Hospital

Boston, Massachusetts 

William Freeman, M.D., M.P.H.

Research Director

Indian Health Service 

Public Health Service

U.S. Department of Health and Human Services

Albuquerque, New Mexico 

Maria Freire, Ph.D.

Director

Office of Technology Transfer

National Institutes of Health

Bethesda, Maryland 

Bruce Fuchs, Ph.D. 

Acting Director

Office of Science Education

National Institutes of Health

Bethesda, Maryland 

Sheryle Gallant, Ph.D.

Associate Professor of Psychology

Department of Psychology

University of Kansas

Lawrence, Kansas 

Sarah Garber, Ph.D.

Associate Professor of Physiology

Department of Physiology

Allegheny University of the Health Sciences

MCP – Hahnemann University School of Medicine

Philadelphia, Pennsylvania 

Marilyn Gaston, M.D.

Assistant Surgeon General

Director

Bureau of Primary Health Care

Bethesda, Maryland 

W. Lou Glasse, M.S.W.

President Emerita

Older Women’s League

Vassar College

Poughkeepsie, New York 

John Glick, M.D.

Director

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania 

Irma Goertzen

President and Chief Executive Officer

Magee-Women’s Hospital

Pittsburgh, Pennsylvania 

Eileen Gorman, Ph.D.

Senior Research Associate

Dade Chemistry Systems

Newark, Delaware 

Patricia Grady, Ph.D.

Director

National Institute of Nursing Research

National Institutes of Health

Bethesda, Maryland 

Phyllis Greenberger, M.S.W.

Executive Director

Society for the Advancement of Women’s 

Health Research

Washington, District of Columbia

Jeane Ann Grisso, M.D., M.Sc.

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania 

Raquel Gur, M.D., Ph.D.

Professor and Director of Neuropsychiatry

Department of Psychiatry

University of Pennsylvania

Philadelphia, Pennsylvania 

Ruben Gur, Ph.D.

Director

Brain Behavior Laboratory

University of Pennsylvania

Philadelphia, Pennsylvania 

Betty Hambleton

Women’s Health Coordinator

Health Resources and Services Administration

Rockville, Maryland 

Della Hann, Ph.D.

Chief

Interpersonal and Family Processing Program

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland 

Hazel Harper, D.D.S.

Hazel Harper & Associates

Washington, District of Columbia
482

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Janet Henrich, M.D.

Associate Professor of Medicine and Gynecology

Primary Care Center

Yale University School of Medicine

New Haven, Connecticut

Enrique Hernandez, M.D.

Professor and Director of Gynecologic Oncology

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Penelope Hitchcock, D.V.M.

Chief, Sexually Transmitted Diseases Branch

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

Eileen Hoffman, M.D.

Assistant Professor of Medicine

Associate Director for Education

Mount Sinai Women’s Health Program

New York, New York

Ann Honebrink, M.D.

Co-Director, Center for Women’s Health

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Marc Horowitz, J.D.

Director, Office of Loan Repayment and Scholarship

Office of Intramural Research

Office of the Director

National Institutes of Health

Bethesda, Maryland

Howard Hu, M.D., Sc.D.

Associate Professor of Occupational Medicine

Channing Laboratory

Boston, Massachusetts

Carole Hudgings, Ph.D.

Program Officer

Office of Alternative Medicine

National Institutes of Health

Bethesda, Maryland

Joseph Hurd, Jr., M.D.

Chairman, Department of Gynecology

Lahey Hitchcock Clinic

Burlington, Massachusetts

Debbie M. Jackson, M.A.

Program Analyst

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Sharon Jackson, M.D.

Clinical Researcher

Laboratory of Host Defense

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland 

Dara Jamieson, M.D.

Department of Neurology

Pennsylvania Hospital

Philadelphia, Pennsylvania 

Marlene Jasperse

Research Specialist

Navajo Division of Health

Navajo Research Program

Window Rock, Arizona

Katrina Johnson, Ph.D.

Research Program Officer

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Wanda Jones, Dr.P.H.

Assistant Director for Women’s Health

Centers for Disease Control and Prevention

Atlanta, Georgia 

Barbara Karp, M.D.

Associate Clinical Director

National Institute of Neurological Disorders 

and Stroke

National Institutes of Health

Bethesda, Maryland 

Gwendolyn Keita, Ph.D.

Director, Women’s Program Office

American Psychological Association

Washington, District of Columbia

M. Margaret Kemeny, M.D.

Chief, Division of Surgical Oncology

Department of Surgery

North Shore University Hospital 

Manhasset, New York 
483

VOLUME2

Mi Ja Kim, Ph.D. Vice Chancellor for Research

Dean of the Graduate College

University of Illinois at Chicago

Chicago, Illinois 

Ruth L. Kirschstein, M.D.

Deputy Director

National Institutes of Health

Bethesda, Maryland 

Barbara Konkle, M.D.

Associate Professor of Medicine

Cardeza Foundation for Hematologic Research

Thomas Jefferson University 

Philadelphia, Pennsylvania 

Howard Kurtzman, Ph.D.

Chief, Cognitive Science Program

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Demie Kurz, M.D.

Co-Director, Women’s Studies

University of Pennsylvania

Philadelphia, Pennsylvania 

Ruth Lamdan, M.D.

Assistant Professor of Psychiatry

Department of Psychiatry

Allegheny University of Health Sciences 

Philadelphia, Pennsylvania 

Marianne Legato, M.D.

Associate Professor of Clinical Medicine 

Columbia University College of Physicians 

and Surgeons

New York, New York 

Ellen Leibenluft, M.D.

Chief, Unit on Rapid-Cycling Bi-Polar Disorder

Clinical Psychopharmacology Branch

National Institute of Mental Health

National Institutes of Health 

Bethesda, Maryland 

Matthew Levison, M.D.

Chair, Infectious Disease

Allegheny University of the Health Sciences 

Philadelphia, Pennsylvania 

Sissel Lund-Katz, Ph.D.

Professor

MCP – Hahnemann School of Medicine

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Joanne Luoto, M.D., M.P.H.

Medical Officer

Contraceptive and Reproductive Evaluation Branch

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland 

Jennifer Madans, Ph.D.

Acting Associate Director of Vital and Health Statistics

National Center for Health Statistics

Hyattsville, Maryland Yvonne Maddox, Ph.D.

Deputy Director

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland 

Worta McCaskill-Stevens, M.D.

Assistant Professor of Medicine

Indiana University

University Hospital

Indianapolis, Indiana 

Catherine McDermott

President and Chief Executive Officer

Grantmakers In Health Washington, District of Columbia

Sonja McKinlay, Ph.D.

President

New England Research Institutes, Inc. Watertown, Massachusetts 

Ruth Merkatz, Ph.D., R.N., F.A.A.N.

Senior Advisor to the Commissioner Women’s Health Issues

Office of Women’s Health

Food and Drug Administration

Rockville, Maryland 

Sherry Mills, M.D., M.P.H.

Cancer Control Research Scientist

Prevention and Control Extramural Branch

National Cancer Institute

National Institutes of Health

Bethesda, Maryland 
484

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Howard Minkoff, M.D.

Professor of Obstetrics and Gynecology

Director of Maternal-Fetal Medicine

Department of Obstetrics and Gynecology

Health Science Center at Brooklyn

State University of New York

Brooklyn, New York 

Donnica Moore, M.D.

Associate Director

Medical Education Center

Sandoz Pharmaceuticals

Neshanic Station, New Jersey 

Diane Morel, Ph.D.

Assistant Professor of Biochemistry

Biochemistry Department

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Mary Morrison, M.D.

Assistant Professor of Psychiatry and Medicine

Department of Psychiatry

University of Pennsylvania

Philadelphia, Pennsylvania 

Donna Murasko, Ph.D.

Professor and Acting Chair

Department of Microbiology and Immunology

MCP – Hahnemann University School of Medicine

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Roberta Ness, M.D., M.P.H.

Assistant Professor of Epidemiology and 

Women’s Health Programs

Graduate School of Public Health

University of Pittsburgh

Pittsburgh, Pennsylvania 

Susan Newcomer, Ph.D.

Statistician (demography)

Demographic and Behavioral Sciences Branch

Center for Population Research

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland 

Christine Maguth Nezu, Ph.D.

Associate Provost for Research

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Judy Norsigian

Co-Director

Boston Women’s Health Book Collective

Somerville, Massachusetts 

Joel Noumoff, M.D.

Director, Division of Gynecologic Oncology

Vice-Chair, Department of Obstetrics and Gynecology

Crozer Chester Medical Center

Upland, Pennsylvania 

Bonnie O’Conner, Ph.D.

Community and Preventive Health

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Suzanne Oparil, M.D.

Director, Vascular Biology and Hypertension Program

Division of Cardiovascular Disease

University of Alabama at Birmingham

Birmingham, Alabama

Nancy Padian, Ph.D.

Associate Professor

Department of Obstetrics, Gynecology 

and Reproductive Science

University of California at San Francisco

San Francisco General Hospital

San Francisco, California

Delores Parron, Ph.D.

Associate Director for Special Populations

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Estella Parrott, M.D., M.P.H.

Coordinator of Research Programs

Office of Research on Minority and Women’s Health

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

Jane Pearson, Ph.D.

Chief, Clinical and Developmental PsychoPathology Program

Mental Disorders of the Aging Research Branch

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland 
485

VOLUME 2

Connie Perry, Ph.D.

Department of Humanities, Social Services, 

and Biometrics

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania

Vivian W. Pinn, M.D.

Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Anthony Piraino, Ph.D.

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania

Jerome Platt, Ph.D.

Professor and Director

Division of Addiction Research and Treatment

Department of Psychiatry

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania

Ellyn J. Pollack, M.A., APR

Information Officer

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Linda Pottern, Ph.D.

Epidemiologist

Women’s Health Initiative

National Institutes of Health

Bethesda, Maryland

Daniel Rader, M.D.

Associate Program Director

General Clinical Research Center

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania

E. Albert Reece, M.D.

Abraham Roth Professor and Professor of 

Internal Medicine

Chairman of Obstetrics and Gynecology

Department of Obstetrics and Gynecology

Temple University School of Medicine

Philadelphia, Pennsylvania 

Eddie Reed, M.D.

Chief, Clinical Pharmacology Branch

National Cancer Institute

National Institutes of Health

Bethesda, Maryland 

David Robinson, Ph.D.

Program Director

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland 

Roxanne Rodney, M.D.

Assistant Professor of Clinical Medicine

Associate Director of Nuclear Cardiology

Division of Cardiology

Columbia University

New York, New York 

Helen Rodriguez-Trias, M.D.

Co-Director, Pacific Institute for Women’s Health

Western Consortium for Public Health

Los Angeles, California 

Judith Ross, M.D.

Professor

Department of Pediatrics

Thomas Jefferson University

Philadelphia, Pennsylvania 

Joyce Rudick

Senior Program Analyst

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Sheryl Ruzek, Ph.D., M.P.H.

Professor of Health Education

Department of Health Education and 

Women’s Studies

Temple University

Philadelphia, Pennsylvania 

Rosalie Sagraves, Pharm.D.

Dean and Professor

University of Illinois at Chicago 

College of Pharmacy

Chicago, Illinois 

Gloria Sarto, M.D., Ph.D.

Professor and Chairperson

Department of Obstetrics and Gynecology

University of New Mexico

Albuquerque, New Mexico 

Anne Sassaman, Ph.D.

Director

Division of Extramural Research and Training

National Institute of Environmental Health Sciences

National Institutes of Health

Research Triangle Park, North Carolina 
486

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Priscilla Schaffer, Ph.D.

Professor and Chair

Department of Microbiology 

University of Pennsylvania School of Medicine 

Philadelphia, Pennsylvania 

Susan Schwartz-Giblin, Ph.D.

Department of Medicine

Allegheny University of the Health Sciences 

Philadelphia, Pennsylvania 

Susana Serrate-Sztein, M.D.

Director, Arthritis Program

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases

National Institutes of Health

Bethesda, Maryland 

Valerie Setlow, Ph.D.

Director, Division of Health Sciences Policy

Institute of Medicine

National Academy of Sciences

Washington, District of Columbia

Moira Shannon, Ed.D., R.N.

Nurse Consultant

Health Resources and Services Administration 

Division of Nursing

U.S. Department of Health and Human Services

Rockville, Maryland 

Eleanor Shore, M.D., M.P.H.

Dean for Faculty Affairs

Harvard Medical School

Boston, Massachusetts 

Marjorie Shultz, J.D., M.A.T.

Professor of Law

Boalt Hall School of Law

University of California at Berkeley

Berkeley, California 

Susan Sieber, Ph.D.

Deputy Director

Division of Cancer Epidemiology and Genetics 

National Cancer Institute

National Institutes of Health

Bethesda, Maryland 

Jamie Siegel, M.D.

Assistant Professor

Medicine and Pathology and Laboratory Medicine 

Division of Hematology/Oncology

Allegheny University of the Health Sciences 

Philadelphia, Pennsylvania 

Elin Sigurdson, M.D., Ph.D.

Director, Surgical Research

Fox Chase Cancer Center

Philadelphia, Pennsylvania 

Emil Skobeloff, M.D.

Department of Emergency Medicine

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Gail Slap, M.D.

Director of Adolescent Medicine

Division of General Internal Medicine

University of Pennsylvania

Philadelphia, Pennsylvania 

Sheryl Smith, Ph.D.

Associate Professor

Department of Neurobiology and Anatomy

Allegheny University of the Health Sciences 

Center City Campus

Philadelphia, Pennsylvania 

Virginia Stallings, M.D.

Chief, Nutrition Section

Division of Gastroenterology and Nutrition 

The Children’s Hospital of Philadelphia 

Philadelphia, Pennsylvania 

Sharilyn Stanley, M.D.

Special Assistant for Science Policy

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland 

Ora Strickland, Ph.D.

Independence Professor

Nell Hodgson Woodruff School of Nursing

Emory University

Atlanta, Georgia 

Brian Strom, M.D., M.P.H.

Chair, Department of Biostatistics and Epidemiology

Director, Center for Clinical Epidemiology 

and Biostatistics

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania 

Anne Summer, M.D.

Assistant Professor

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 
487

VOLUME 2

Ramona Tascoe, M.D., M.H.S.A.

Oakland, California 

Rosemary Torres, J.D., R.N.

Attorney

Sedro Woolley, Washington 

Edward Trimble, M.D., M.P.H.

Head, Surgery Section

Cancer Therapy Evaluation Program

Division of Cancer Treatment, Diagnosis, and Centers

National Cancer Institute

National Institutes of Health

Bethesda, Maryland 

Thomas Tulenko, Ph.D.

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 

Donald Vereen, Jr., M.D., M.P.H. 

Special Assistant for Medical Affairs 

National Institute on Drug Abuse 

National Institutes of Health

Rockville, Maryland 

Frances Visco, J.D.

President

National Breast Cancer Coalition

Philadelphia, Pennsylvania 

Donna Vogel, M.D., Ph.D.

Associate Chief for Clinical Research

Reproductive Sciences Branch 

Center for Population Research

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland 

Eugene Washington, M.D., M.P.H., M.Sc.

Professor and Chair

Department of Obstetrics and Gynecology

University of California at San Francisco

San Francisco, California 

Anita Corman Weinblatt, Ph.D.

Scientific Review Administrator

Division of Research Grants

National Institutes of Health

Bethesda, Maryland 

Constance Weinstein, Ph.D.

Health Scientist Administrator

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland 

Cora Lee Wetherington, Ph.D.

Women’s Health Coordinator

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland 

Nancy S. Wexler, Ph.D.

Higgins Professor of Neuropsychology

Department of Neurology and Psychiatry

College of Physicians and Surgeons

Columbia University

New York, New York 

Judith M. Whalen

Associate Director for Science Policy

Analysis and Communication

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland 

Anne Willoughby, M.D., M.P.H.

Chief

Pediatric, Adolescent, and Maternal AIDS Branch

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland 

Nancy Fugate Woods, Ph.D., R.N., F.A.A.N.

Professor, University of Washington

Director, Center for Women’s Health Research

School of Nursing

Seattle, Washington

Susan Yanovski, M.D.

Director, Obesity and Eating Disorders Program

National Institute of Diabetes and Digestive 

and Kidney Diseases

National Institutes of Health

Bethesda, Maryland 

Darlene Yee, Ed.D., C.H.E.S.

Professor and Director, Gerontology Programs

Former Chair, Committee for the Protection 

of Human Subjects

San Francisco State University

San Francisco, California 
488

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Elizabeth Young, M.D.

Associate Professor Psychiatry

Associate Research Scientist

Mental Health Research Institute

Ann Arbor, Michigan 

Richard Zaino, M.D.

Professor of Pathology

Milton S. Hershey Medical Center

Hershey, Pennsylvania
489

VOLUME 2

Sheraton New Orleans Hotel

New Orleans, Louisiana

June 11-13, 1997

AGENDA

WEDNESDAY, JUNE 11, 1997

PREMEETING ACTIVITIES: PUBLIC HEARING

11:00 a.m. Working Meeting/Lunch

Task Force

Advisory Committee

Local Hosts

Planning Committee

Rapporteurs

1:00-5:00 p.m. Public Testimony: The Women’s Health Research Agenda for the 21st Century

Welcome and Introductory Remarks 

Dr. Vivian W. Pinn

Dr. Ann Anderson

I. State of Knowledge in Women’s Health Across the Life Span

II. Sex and Gender Differences — Impact on Women’s Health

III. New Priorities for Research on Women’s Health

IV. Environmental, Genetic, Hormonal, Nonhormonal, and Other Factors 

that Impact on Women’s Health

V. Career Issues for Women Scientists and How To Overcome Barriers

5:15-6:00 p.m. Meetings/Interviews with Testifiers, Participants, and Local Press

6:00-7:30 p.m. Meeting with Task Force/Ad Hoc

Working Group and Cochairs

Local Hosts

Working Dinner

Dr. Vivian W. Pinn

BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH

FOR THE 21 S T CENTURY
490

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

THURSDAY, JUNE 12, 1997

SCIENTIFIC WORKSHOP DAY 1

Physiological, Psychosocial, and Pharmacologic Differences Between Women and Men

8:30 a.m. Opening Plenary Session 

Dr. Vivian W. Pinn

Welcoming Remarks and Introductions 

Dr. Judith LaRosa

Dr. John Estrada

Ms. Sybil Morial

Comments 

Dr. John LaRosa

Chancellor, TUMC

9:00 a.m. Overview: Beyond Hunt Valley: Research on Women’s Health for the 21st Century

Dr. Vivian W. Pinn

9:30 a.m. Plenary Address — Is It All Steroidal Sex Hormones?

Dr. Michael Lockshin

Moderator

Dr. John Estrada

10:00 a.m. Break

10:30 a.m. Panel Discussion: Physiological, Psychosocial, and Pharmacologic Differences 

Between Women and Men

Moderator

Dr. Shiriki Kumanyika

Physiological Differences Between Women and Men 

Dr. Marianne Legato

Psychosocial Differences Between Women and Men 

Dr. Vickie Mays

Pharmacologic Differences Between Women and Men 

Dr. Raymond Woosley

Biological homogeneity exists. Similarly, differences exist, especially between the sexes. 

For too long these differences were not appreciated — from the most basic cellular level 

to the vast expanse of behavior. What’s the same and what’s different? How do the 

differences affect research design and execution; health status; health care?

12:00 p.m. Charge to the Working Groups

Dr. Marianne Legato

Dr. Donna Dean

12:30 p.m. Lunch
491

VOLUME 2

1:30 p.m. Breakout to Working Groups 

Prenatal, Infancy, and Childhood Years (prenatal to puberty)

Adolescent Years (puberty to 18 years)

Reproductive and Middle Years

Perimenopausal and Postmenopausal Years

Elderly and Frail Elderly Years (65+)

3:30 p.m. Break

4:15 p.m. Working Group Interim Reports

Dr. Marianne Legato

Dr. Donna Dean

5:30 p.m. Adjourn

6:00 p.m. Reception

New Orleans Jazz Reception — Tulane/Xavier Center for Bioenvironmental Research

FRIDAY, JUNE 13, 1997

SCIENTIFIC WORKSHOP DAY 2

9:00 a.m. Comments

Dr. Vivian W. Pinn

9:15 a.m. Plenary Address: Emerging Issues in Research: Environment, Genetic/Genomic, 

and Hormones

Dr. John McLachlan

Moderator

Dr. Terry Damstra

10:30 a.m. Break

10:45 a.m. Concurrent Working Groups (continue)

12:00 noon Break

12:15 p.m. Lunch

Introduction

Dr. Judith LaRosa

Speaker

The Honorable Lindy Boggs

1:30 p.m. Working Group Reports

Dr. Marianne Legato

Dr. Donna Dean

3:00 p.m. Closing Remarks/Adjourn

Dr. Vivian W. Pinn
492

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Claudia R. Baquet, M.D., M.P.H.

Associate Dean

University of Maryland School of Medicine

Baltimore, Maryland

Evelyn Bartfield, Ph.D.

Assistant Professor

School of Dentistry

Marquette University

Milwaukee, Wisconsin

Consuelo Beck-Sagúe, M.D.

Associate Director

Minority and Women’s Health

Centers for Disease Control and Prevention

Atlanta, Georgia

Gerald S. Berenson, M.D.

Director, Center for Cardiovascular Health

School of Public Health

Tulane University Medical Center

New Orleans, Louisiana 

Michelle Berlin, M.D., M.P.H.

Assistant Professor of Obstetrics and Gynecology, 

and Epidemiology

Center for Clinical Epidemiology and Biostatistics

University of Pennsylvania

Philadelphia, Pennsylvania 

The Honorable Lindy Boggs

Tulane University

New Orleans, Louisiana 

Mary L. Bowers

Program Liaison Specialist

Office of Women’s Health

Dallas, Texas

Edward N. Brandt, Jr., M.D., Ph.D.

Professor and Director

Center for Health Policy Research

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 

Beyond Hunt Valley: 

Research on Women’s Health for the 21ST Century

NEW ORLEANS, LOUISIANA

JUNE 11-13, 1997

PARTICIPANTS

Dyanne D. Affonso, Ph.D., F.A.A.N.

Dean and Professor

Nell Hodgson Woodruff School of Nursing

Emory University

Atlanta, Georgia 

Geriane Alexander, Ph.D.

Assistant Professor

Department of Psychology

University of New Orleans

New Orleans, Louisiana 

Ann C. Anderson, Ph.D.

Senior Associate Dean

Office of the Dean

School of Public Health

Tulane University

New Orleans, Louisiana

Ruth A. Anderson, D.D.S.

Associate Professor 

Pediatric Dentistry 

College of Dentistry

Howard University

Washington, District of Columbia

Valerie J. Andrews, M.J.

Editor, Spectrum Unlimited

Journal for Minority Medical Students

New Orleans, Louisiana

Marietta Anthony, Ph.D.

Acting Deputy Director

Office of Research on Women’s Health

Food and Drug Administration

Rockville, Maryland

Marilyn N. Arnold

Vice President

Clinix International, Inc.

Chicago, Illinois
493

VOLUME 2

Diane Brown, Ph.D.

Professor and Director

Urban Health Program

Wayne State University

Detroit, Michigan 

Michael Brown

Health Scientist

Office of Women’s Health

Centers for Disease Control and Prevention 

Atlanta, Georgia 

Molly Chatterjee, M.D.

Professor

Director of Maternal Fetal Medicine

Department of Obstetrics and Gynecology

Meharry Medical College

Brentwood, Tennessee 

Margaret M.L. Chu, Ph.D.

Environmental Scientist

National Center for Environmental Assessment

Office of Research Development

U.S. Environmental Protection Agency

Washington, District of Columbia

Mary T. Chunko, M.A.

Information Development Scientist

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Lisa Cox

Program Director

National Women’s Health Network

Washington, District of Columbia

Terri Damstra, Ph.D.

Special Assistant to the Director

Tulane/Xavier Center for Bioenvironmental Research

Tulane University Medical School

New Orleans, Louisiana 

Katherine Davenny, M.P.H.

Research Epidemiologist

Clinical Medicine Branch

Division of Clinical Services Research

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland 

Barbara J. Davis, M.D.

Environmental Carcinogenesis Program

National Institute of Environmental Health Sciences

National Institutes of Health

Research Triangle Park, North Carolina 

Donna Dean, Ph.D.

Acting Chief

Referral and Review Branch

Division of Research Grants

National Institutes of Health

Bethesda, Maryland

Anthony Del Conte, M.D.

Associate Director

Clinical Research

Wyeth-Ayerst Research

Radnor, Pennsylvania 

Linda DePugh

Administrative Assistant

Division of Health Sciences Policy

Institute of Medicine

National Academy of Sciences

Washington, District of Columbia

Bobbie Dill, R.N., B.S.N.

Program Director

Behavioral Medicine Solutions of Virginia

Roanoke, Virginia 

James E. Dill, M.D.

President-Director

Behavioral Medicine Solutions of Virginia

Roanoke, Virginia

Eloise D. Dixon, M.S.W.

Director

Counseling Center

Xavier University

New Orleans, Louisiana 

Chhanda Dutta, Ph.D.

Health Scientist Administrator

Geriatrics Program

National Institute on Aging

National Institutes of Health

Bethesda, Maryland 

Joan P. Eitzen, Ph.D.

Director

Health Promotion and Wellness

U.S. Army

Edgewood (APG), Maryland 
494

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Carolyn Evans, M.S.W.

Clinical Program Director

Grace House of New Orleans, Inc.

New Orleans, Louisiana 

Loretta Finnegan, M.D.

Director

Women’s Health Initiative

National Institutes of Health

Bethesda, Maryland 

Wonda L. Fontenot, Ph.D.

Executive Director

Wannamuse Institute

Opelousas, Louisiana 

Julia B. Freeman, Ph.D.

Director, Centers Program

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases

National Institutes of Health

Bethesda, Maryland 

Irma E. Goertzen

President and Chief Executive Officer

Magee-Women’s Hospital

Pittsburgh, Pennsylvania 

Julie E. Goslee, Pharm.D.

Assistant Professor of Clinical Pharmacy

College of Pharmacy

Xavier University of Louisiana 

New Orleans, Louisiana 

Phyllis Greenberger, M.S.W.

Executive Director

Society for the Advancement of Women’s 

Health Research

Washington, District of Columbia

Alton E. Hadley

Assistant Secretary

Department of Health and Hospitals 

State of Louisiana Office of Alcohol and Drug Abuse 

Baton Rouge, Louisiana 

B. Joe Hailey, Ph.D.

Professor

Psychology Department

University of Southern Mississippi

Hattiesburg, Mississippi 

Sandra J. Hamilton, R.N., F.N.P. 

Director

National Black Leadership Initiative on Cancer

Instructor and Assistant Clerkship Coordinator 

Department of Internal Medicine

Meharry Medical College

Nashville, Tennessee 

Eleanor Hanna, Ph.D.

Special Expert

Division of Biology and Epidemiology

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

Bethesda, Maryland 

J. Taylor Harden, Ph.D., R.N.

Assistant to the Director for Special Populations

National Institute on Aging

National Institutes of Health

Bethesda, Maryland 

Suzanne G. Haynes, Ph.D.

Assistant Director of Science

Office of Women’s Health

Public Health Service

Washington, District of Columbia

Saletta Holloway

Council Representative 

29th District, Nashville and Davidson Counties 

Meharry Medical College 

Nashville, Tennessee 

Sharon D. Hunter

Contracting Officer

U.S. Coast Guard

Grand Alameda, California 

Anna M. Jackson, Ph.D.

Professor

Assistant Dean for Student Affairs

School of Dentistry, Meharry Medical College

Nashville, Tennessee 

Carol Jackson, M.P.A., R.N.

Assistant Professor and Deputy Director

Area Health Education Centers

Director, AIDS Education and Training Center

Department of Family and Preventive Medicine

Meharry Medical College

Nashville, Tennessee 
495

VOLUME 2

Wendy Johnson

Reporter

The Washington Blade

Washington, District of Columbia

Winniefred Jones, M.N., R.N.

Assistant Professor

Charity School of Nursing

Delgado College

New Orleans, Louisiana 

Marlene Keeling

Founding Director

CANDO

Houston, Texas 

Teresa R. Kendrix

Administrative Officer

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Maurice Knuckles, Ph.D.

Assistant Professor

Director, Environmental Health

Department of Family and Preventive Medicine

Meharry Medical College

Nashville, Tennessee 

Shiriki Kumanyika, Ph.D., R.D., M.P.H.

Professor of Nutrition and Epidemiology

Head, Department of Human Nutrition and Dietetics

University of Illinois at Chicago

Chicago, Illinois 

John Charles LaRosa, M.D.

Chancellor

Tulane University Medical School

New Orleans, Louisiana 

Judith H. LaRosa, Ph.D., R.N., F.A.A.N.

Clinical Professor of Public Health

Tulane University

New Orleans, Louisiana 

Clarissa D.W. LaSalle

Program Assistant

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Verna E. Lee

Program Manager

Center for Bioenvironmental Research

Tulane University

New Orleans, Louisiana 

Marianne Legato, M.D.

Associate Professor of Clinical Medicine 

Columbia University College of Physicians 

and Surgeons

New York, New York 

Richard R.J. Lewine, Ph.D.

Professor and Director of Psychiatry

Schizophrenic Disorders Program

School of Medicine, Emory University

Atlanta, Georgia 

Marva L. Lewis, Ph.D.

Assistant Professor

School of Social Work

Tulane University

New Orleans, Louisiana 

Michael D. Lockshin, M.D.

Director and Professor

Barbara Volcker Center for Women and 

Rheumatic Diseases

Hospital for Special Surgery

New York, New York

Jennifer C. Lovejoy, Ph.D.

Assistant Professor

Pennington Biomedical Research Center

Baton Rouge, Louisiana 

Barbara S. Lynch, Ph.D.

Director

Technical and Logistical Support Services

Prospect Associates

Rockville, Maryland 

Frances Mather, Ph.D.

Associate Professor

Department of Biostatistics and Epidemiology

Tulane University

New Orleans, Louisiana 

Vickie M. Mays, Ph.D.

Department of Psychology

University of California, Los Angeles

Los Angeles, California 

Wendy McGoodwin

Council for Responsible Genetics

Cambridge, Massachusetts 

John A. McLachlan, Ph.D.

Director

Tulane/Xavier Center for Bioenvironmental Research

Professor of Pharmacology

Tulane University

New Orleans, Louisiana 
496

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Rebecca A. Meriwether, M.D., M.P.H.

Director

Health Protection/Disease Prevention Division

National Institutes of Health

New Orleans, Louisiana 

Sybil Morial

Associate Vice President of Public Affairs 

and Communications

Xavier University of Louisiana

New Orleans, Louisiana 

Danita M. Muse, M.S.W.

Program Coordinator

Women With a Vision, Inc.

New Orleans, Louisiana 

Peter W. Nathanielsz, M.D., Ph.D., Sc.D.

James Law Professor of Reproductive Physiology

Director, Laboratory for Pregnancy and 

Newborn Research

Department of Physiology

College of Veterinary Medicine

Cornell University

Ithaca, New York 

Lawrence M. Nelson, M.D.

Staff Scientist and Senior Surgeon

Section on Women’s Health

Developmental Endocrinology Branch

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland 

Cherie M. Nichols, M.B.A.

Chief

Planning Evaluation and Analysis Branch

Office of Special Populations

Office of the Director

National Cancer Institute

National Institutes of Health

Bethesda, Maryland 

Marcy Ouellette, M.D., M.P.H., T.M.

Medical Director 

Women’s Health

Louisiana Office of Public Health

New Orleans, Louisiana 

Nancy Padian, Ph.D.

Associate Professor

Department of Gynecology and Reproductive Science

University of California at San Francisco

San Francisco General Hospital

San Francisco, California 

Eileen M. Palace, Ph.D.

Director

The Center for Sexual Health 

Associate Professor

Departments of Psychiatry and Neurology, 

Obstetrics and Gynecology, Urology, and Surgery

Tulane University School of Medicine

New Orleans, Louisiana 

Estella Parrott, M.D., M.P.H. 

Coordinator of Research Programs 

National Institute of Allergy and Infectious Disease

Office of Research on Minority and Women’s Health

National Institutes of Health 

Bethesda, Maryland 

Vivian W. Pinn, M.D.

Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Ellyn J. Pollack, M.A., APR

Information Officer

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Elizabeth Rahdert, Ph.D.

Treatment Research Branch

Division of Clinical and Services Research

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland 

Amelie G. Ramirez, Dr.P.H. 

Associate Professor

Associate Director

Center for Cancer Control Research

Baylor College of Medicine 

Houston, Texas 

Jayashree Rao, M.D.

Associate Professor

Department of Pediatrics

Louisiana State University Medical Center 

New Orleans, Louisiana 

Colonel Irene M. Rich, D.N.Sc. 

Director

Congressional Special Interest Research Programs 

U.S. Army Medical Research and Materiel Command 

Fort Detrick, Maryland 
497

VOLUME 2

B.J. Richardson, M.D.

Women’s College Hospital

Toronto, Ontario, Canada

C.B. Robinowitz, M.D.

Associate Dean

School of Medicine

Georgetown University School of Medicine 

Washington, District of Columbia

Adele Roman, R.N., M.S.W.

Deputy Women’s Health Coordinator

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland 

Joyce Rudick

Acting Deputy Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Shirley B. Russell, Ph.D. 

Professor and Chair

Department of Microbiology

Associate Dean for Research, School of Dentistry

Meharry Medical College

Nashville, Tennessee 

Geri Scheller-Gilkcey, Ph.D.

Assistant Professor of Psychiatry and 

Behavioral Sciences, Medical School

Emory University

Atlanta, Georgia 

Valerie Setlow, Ph.D.

Director

Division of Health Sciences Policy

Institute of Medicine

National Academy of Sciences

Washington, District of Columbia

Meghan-Morgan Shannon, M.S.

Co-Coordinator

Medical Professionals/Persons with CFIDS/CFS/ME

Cardiff, California 

Amanda Sherman

President

DES Action USA

Oakland, California 

Denese Shervington, M.D., M.P.H. 

Institute of Women and Ethnic Studies 

New Orleans, Louisiana 

Linda C. Skidmore, M.S.

Director

Committee on Women in Science and Engineering

National Research Council

Washington, District of Columbia

Courtenay Smith

Editorial Assistant

Woman’s Day

New York, New York 

Sharilyn Stanley, M.D.

Special Assistant for Science Policy

Office of the Director

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland 

Ana Szarfman, M.D., Ph.D.

Medical Officer

Special Assistant to the Director of the Office 

of Epidemiology and Biostatistics

Center for Drug Evaluation

Food and Drug Administration

Rockville, Maryland 

Ramona Tascoe, M.D.

Chair, Council on the Concerns of Women Physicians

National Medical Association

Oakland, California 

Anita Corman Weinblatt, Ph.D.

Scientific Review Administrator

Division of Research Grants

National Institutes of Health

Bethesda, Maryland 

Judith Whalen, M.P.A.

Associate Director

Office of Science Policy, Analysis and Communication

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland 

Beth Willinger, Ph.D.

Director

Newcomb College Center for Research on Women

Tulane University

New Orleans, Louisiana 

Raymond Woosley, M.D., Ph.D.

Professor and Chairman

Department of Pharmacology

Georgetown University Medical Center

Washington, District of Columbia

Santa Fe Hilton Hotel

Santa Fe, New Mexico

July 21-23, 1997

AGENDA

Sponsored by: Office of Research on Women’s Health

National Institutes of Health

Hosted by: University of New Mexico

School of Medicine

University of Iowa

College of Pharmacy

MONDAY, JULY 21, 1997

PUBLIC HEARING DAY 1

9:00-11:00 a.m. Meeting

Task Force

Working Group Cochairs

Rapporteurs

1:00-2:40 p.m. Public Testimony: Women’s Health Research for the 21st Century

I. Continuing or Emerging Gaps in Knowledge About Women’s Health Across 

the Life Span

II. Population Differences: Race, Culture, and Ethnicity and Their Impact 

on Women’s Health

III. Women with Special Health Concerns: Recommendations for Future Research

IV. Career Issues for Women Scientists

2:40-3:00 p.m. Break

3:00-5:00 p.m. Public Testimony continues

499

VOLUME 2

BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH

FOR THE 21 S T CENTURY
500

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

TUESDAY, JULY 22, 1997

SCIENTIFIC WORKSHOP DAY 2

Special Populations of Women: Factors Impacting Health and the Scientific 

Research Agenda

7:00 a.m.-6:30 p.m. Conference Registration 

7:00-8:00 a.m. Continental Breakfast 

8:00 a.m.-12:00 p.m. Opening Plenary Session

8:00-8:20 a.m. Opening Remarks

Dr. Vivian W. Pinn

Welcoming Remarks

Dr. Gloria E. Sarto

Dr. Mary J. Berg

8:20-8:50 a.m. Overview: Beyond Hunt Valley: Research on Women’s Health for the 21st Century

Dr. Vivian W. Pinn

8:50-9:10 a.m. The Health of Special Populations of Women: Implications for Research

Dr. Gloria E. Sarto

9:10-10:15 a.m. Panel Discussion: Definitions of Race, Culture, and Ethnicity

Moderator

Dr. Vanessa Gamble

OMB: Current Activities

Ms. Katherine Wallman

Anthropological Perspectives

Dr. Louise Lamphere

Comments: Implications for NIH-Funded Research

Dr. Belinda Seto

Dr. Otis Brawley

Discussion

10:15-10:30 a.m. Break

10:30-11:30 a.m. Panel Discussion: Impact of Traditional and Cultural Health Practices

Introduction

Dr. Gloria Sarto

Co-Moderators

Dr. Linda Burhansstipanov

Dr. Amelie Ramirez
501

VOLUME 2

Asian

Dr. Barbara Yee

Hispanic

Dr. Helen Rodriguez-Trias

Hawaiian

Dr. Carol Korenbrot

African American

Dr. Marcia Bayne-Smith

Doctor-Patient Relationships

Dr. Marianne Legato

11:30-11:55 a.m. Discussion

11:55 a.m.-12:00 p.m. Charge to Working Groups

Dr. Marianne Legato

Dr. Donna Dean

12:00-1:15 p.m. Lunch

Introduction of Speaker

Dr. Amelie Ramirez

Traditional Mexican Folk Medicine and Folk Beliefs: Their Influence in the Southwest

Dr. Eliseo “Cheo” Torres

1:30-4:15 p.m. Convening of Working Groups by Life Span

Prenatal Years

Infancy and Childhood Years

Adolescent Years

Reproductive and Middle Years 

Perimenopausal Years

Postmenopausal Years 

Elderly and Frail Elderly Years

Career Issues for Special Populations of Women Scientists

4:15-4:30 p.m. Break

4:30-6:15 p.m. Plenary Session

4:30-6:15 p.m. Panel Discussion: Cancer Genetics and Its Implications for Different Populations 

of Women

Moderator

Dr. Karen Antman

Breast Cancer Genetics

Dr. Barbara Weber
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Breast Cancer Epidemiology

Dr. Elizabeth Schubert

Decision Analysis

Dr. Deborah Shrag

Ethics

Dr. Joan Gibson

Genetic Counseling

Ms. Stephanie Smith

Discussion

6:15 p.m. Adjourn

6:30 p.m. Networking Reception — Native American Dance Program

WEDNESDAY, JULY 23, 1997

SCIENTIFIC WORKSHOP DAY 3

7:00-8:00 a.m. Continental Breakfast

8:15-9:30 a.m. Plenary Session 

8:00-8:15 a.m. Opening Comments

Dr. Vivian W. Pinn

8:15-8:45 a.m. Introduction of Speaker

Dr. Mary J. Berg

Psychosocial, Behavioral, and Educational Factors that Affect Population 

Differences in Health Among Women

Dr. Norman Anderson

8:45-9:00 a.m. Discussion

9:00-9:15 a.m. Introduction of Speaker

Dr. George Bryan

Health Issues for Women with Disabilities

Ms. Carol Howland

9:15-9:30 a.m. Discussion
503

VOLUME 2

9:30-9:45 a.m. Break

9:45 a.m.-12:00 p.m. Concurrent Working Groups (continue)

12:15-1:15 p.m. Lunch

Introduction of Native American Cultural Program

Dr. Linda Burhansstipanov

Where Tradition Meets Science: Traditional Practices in Conflict with Western Medicine

Dr. Tieraona Low Dog

1:15-2:30 p.m. Closing Plenary Session

1:15-2:25 p.m. Plenary: Working Group Reports

Working Group Cochairs

Discussion

2:25-2:30 p.m. Closing Remarks/Adjourn

Dr. Vivian W. Pinn
504

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH FOR THE 21ST CENTURY

SANTA FE, NEW MEXICO

JULY 21-23, 1997

PARTICIPANTS

Lucile Adams-Campbell, Ph.D.

Director

Cancer Center

Professor of Medicine

Howard University

Washington, District of Columbia

Puaalaokalani D. Aiu, Ph.D.

Research and Statistics Officer

Papa Ola Lokahi

Honolulu, Hawaii 

Norman Anderson, Ph.D.

Associate Director for Behavioral and 

Social Sciences Research

National Institutes of Health

Bethesda, Maryland

Ruth A. Anderson, D.D.S.

Associate Professor

Pediatric Dentistry

College of Dentistry

Howard University

Washington, District of Columbia

Karen Antman, M.D.

Professor of Medicine

Columbia University

Chief, Division of Medical Oncology

Columbia Presbyterian Comprehensive Cancer Center

New York, New York

Juanita Archer, M.D., M.S.

Associate Professor of Endocrinology and Metabolism

Howard University College of Medicine

Washington, District of Columbia

Margarita Archibeque, M.S.

Education Coordinator

New Mexico Breast and Cervical Cancer Program

Albuquerque, New Mexico 

Marilyn N. Arnold

Vice President

Clinix International, Inc.

Chicago, Illinois 

Constance W. Atwell, Ph.D.

Associate Director for Extramural Activities 

National Institute of Neurological Disorders 

and Stroke

National Institutes of Health

Bethesda, Maryland 

Marcia Bayne-Smith, D.S.W., A.C.S.W.

Assistant Professor

Urban Studies Department

Queen’s College

City University of New York

Flushing, New York

Lula Beatty, Ph.D.

Chief

Special Populations Office

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland

Consuelo Beck-Sagué, M.D.

Associate Director for Minority and Women’s Health

Centers for Disease Control and Prevention

Atlanta, Georgia

Mary J. Berg, Pharm.D.

Professor

Division of Clinical and Administrative Pharmacy

College of Pharmacy

University of Iowa

Iowa City, Iowa

Sarah Berger, M.P.H.

Research Associate

The Lovelace Institutes

Albuquerque, New Mexico

Michelle Berlin, M.D., M.P.H.

Assistant Professor of Obstetrics and Gynecology, 

and Epidemiology and Biostatistics

University of Pennsylvania

Philadelphia, Pennsylvania
505

VOLUME 2

Mary C. Blehar, Ph.D.

Chief

Mood, Anxiety, and Personality Disorders 

Research Branch

National Institute of Mental Health 

National Institutes of Health

Rockville, Maryland

Beate Blennemann, Ph.D., R.D., L.D. 

Project Leader

Ross Products Division

Columbus, Ohio

Mary L. Bowers, M.S.W. 

Program Liaison Specialist 

Office on Minority Health

Dallas, Texas

Otis Brawley, M.D.

Director

Office of Special Populations

Office of the Director

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Diane Brown, Ph.D.

Professor and Director

Urban Health Program

Wayne State University

Detroit, Michigan

Linda Burhansstipanov, M.S.P.H., Dr.P.H.

Director

AMC Native American Cancer Center

AMC Cancer Research Center

Denver, Colorado

Delia Camacho, Ph.D.

Professor/Director Women’s Health Center

University of Puerto Rico

Medical Campus

San Juan, Puerto Rico

Jeanne Carritt, M.A., E.Ed.

Albuquerque, New Mexico

Jean Charles-Azure, M.P.H., R.D.

Director, Nutrition and Dietetics Training Program

Indian Health Service

Santa Fe, New Mexico 

Mary T. Chunko, M.A.

Information Development Specialist

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Marta Clark, Ph.D.

Vice President

Community Development

St. Vincent Hospital

Santa Fe, New Mexico 

Zara Cooper

Medical Student-Summer Intern

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Jane Cotner, M.S.

Cancer Control Coordinator

New Mexico Department of Health

Albuquerque, New Mexico 

Jennifer H. Cousins, Ph.D.

Director

Center for Women’s Health

Baylor College of Medicine

Houston, Texas

Alice J. Dan, Ph.D.

Director

Center for Research on Women and Gender

University of Illinois at Chicago

Chicago, Illinois 

William Darity, Ph.D.

Dean and Professor Emeritus

University of Massachusetts at Amherst

Amherst, Massachusetts 

Katherine Davenny, M.P.H.

Health Scientist Administrator and 

Research Epidemiologist

National Institute on Drug Abuse

National Institutes of Health

Division of Clinical and Services Research

Rockville, Maryland 

Colonel Laurie Davis, Ph.D.

Women’s Health Coordinator

United States Army

Tripler Army Medical Center

Tamc, Hawaii
506

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Donna Dean, Ph.D.

Acting Chief

Referral and Review Branch

Division of Research Grants

National Institutes of Health

Bethesda, Maryland

Linda DePugh

Administrative Assistant 

Division of Health Sciences Policy

Institute of Medicine

National Academy of Sciences

Washington, District of Columbia

Catherine Didion

Executive Director

Association for Women in Science

Washington, District of Columbia

Bobbie Dill, B.S.N., R.N.

Program Director

Behavioral Medicine Solutions of Virginia

Roanoke, Virginia 

Tieraona Low Dog, M.D.

Biomedical Research Facility

University of New Mexico Health Sciences Center

Albuquerque, New Mexico

Howard Dubowitz, M.D.

Associate Professor in Pediatrics

Director, Child Protection Program

University of Maryland School of Medicine

Baltimore, Maryland 

Deborah Guadalupe Durán, Ph.D. 

Director

Cancer Program for Women 

National Coalition of Hispanic Health

COSSMHO

Washington, District of Columbia

Roberta Duran

Disability Prevention, Public Health Educator

Department of Health/Public Health Division

Santa Fe, New Mexico 

Thomas R. Eng, V.M.D., M.P.H.

Senior Program Officer

Institute of Medicine

Washington, District of Columbia

Sally Esposito, M.S.

Director

Department of Services for Persons With Disability

New Haven, Connecticut 

Dione Farria, M.D., M.P.H.

UCLA Medical Center

Department of Radiological Sciences

Culver City, California 

Rosa Vivian Fernandez, M.P.H.

Health Care Administrator

New Mexico Department of Health

Behavioral Health

Santa Fe, New Mexico 

Doris Fields, M.A.

New Mexico Turning Point Coordinator

New Mexico Department of Health

Santa Fe, New Mexico

R. Louise Floyd, R.N., D.S.N.

Chief

Fetal Alcohol Syndrome Prevention

Centers for Disease Control and Prevention

Atlanta, Georgia 

Vanessa Northington Gamble, M.D., Ph.D.

Assistant Professor

University of Wisconsin School of Medicine

Madison, Wisconsin

Joan M. Gibson, Ph.D.

Director, Health Sciences Ethics Program

University of New Mexico

Albuquerque, New Mexico

Barry E. Halber

President

Wilbar Health Productions

Sunrise, Florida 

Janet Hall, M.D.

Assistant Professor of Medicine

Harvard Medical School

Assistant Chief of Reproduction

Endocrine Unit

Massachusetts General Hospital

Boston, Massachusetts

Glenna Halvorson-Boyd, Ph.D.

President

Halvorson-Boyd & Bell

Santa Fe, New Mexico 

Betty B. Hambleton

Senior Advisor

Women’s Health

Health Resources and Services Administration

Rockville, Maryland 
507

VOLUME 2

Suzanne G. Haynes, Ph.D.

Assistant Director of Science

Office of Women’s Health

Public Health Service

Washington, District of Columbia

Jane E. Henney, M.D.

Vice President for Health Sciences

University of Mexico Health Sciences Center

Albuquerque, New Mexico 

Albert Hergenroeder, M.D.

Associate Professor of Pediatrics

Baylor College of Medicine

Texas Children’s Hospital

Houston, Texas 

Michelle Hoersch, M.S.

Director

Region V 

Office on Women’s Health

U.S. Public Health Service

Chicago, Illinois 

Carol Howland, M.P.H.

Assistant Professor and Associate Director

Center for Research on Women with Disabilities

Baylor College of Medicine

Houston, Texas

Carol Hudgings, Ph.D.

Program Officer

Office of Alternative Medicine

National Institutes of Health

Bethesda, Maryland 

Elizabeth Hutchinson

San Juan CIL

Santa Fe, New Mexico

Debbie M. Jackson, M.A.

Program Analyst

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Carol Johnson, M.P.H.

Public Health Advisor

Centers for Disease Control and Prevention

Indian Health Service

Albuquerque, New Mexico

Wendy Johnson

Reporter

The Washington Blade

Washington, District of Columbia

Wanda K. Jones, Dr.P.H.

Associate Director for Women’s Health

Centers for Disease Control and Prevention

Atlanta, Georgia 

Penelope Kegel-Flom, Ph.D.

Associate Professor

College of Optometry

University of Houston

Houston, Texas 

Teresa R. Kendrix

Administrative Officer

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Marianna Kennedy, M.S.W., M.P.A.

Director

Pueblo of Jemez Health Department

Jemez Pueblo, New Mexico 

David Kerns, M.D.

Chairman

Department of Pediatrics

Santa Clara Valley Medical Center

San Jose, California 

Judith Kitzes, M.D., M.P.H.

Chief Medical Officer

Indian Health Services

Albuquerque, New Mexico 

Patti Klein, Ph.D.

Epidemiologist

Dow Corning Corporation

Midland, Michigan 

Rose Koremenos, R.N., B.S.N.

Women’s Health Education Coordinator

Elmbrook Memorial Hospital

Brookfield, Wisconsin 

Carol C. Korenbrot, Ph.D.

Associate Professor

Institute for Health Policy Studies

Department of Obstetrics, Gynecology and 

Reproductive Sciences

University of California School of Medicine

San Francisco, California

Helen Kornblum, M.S.W.

Psychotherapist

Clayton, Missouri 
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Diana Koster, M.D.

Medical Director

Planned Parenthood of New Mexico

Albuquerque, New Mexico 

Marilyn Poland Laken, Ph.D.

Professor of Obstetrics and Gynecology

Wayne State University School of Medicine

Detroit, Michigan 

Louise Lamphere, Ph.D.

Professor of Anthropology

University of New Mexico

Albuquerque, New Mexico

Clarissa D.W. LaSalle

Program Assistant

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Marianne J. Legato, M.D., F.A.C.P.

Director

Partnership for Women’s Health

Department of Medicine

Columbia University

New York, New York

Wilhelmina A. Leigh, Ph.D.

Senior Research Associate

Joint Center for Political and Economic Studies

Washington, District of Columbia

Julianna Lerner, Ph.D.

Coordinator

DES Action New Mexico

Albuquerque, New Mexico 

Judith A. Lewis, Ph.D., R.N.C., F.A.A.N.

Associate Professor and Chair, MCN

Virginia Commonwealth University

Richmond, Virginia 

Susan Lewis

ALBQ, ILRC

Santa Fe, New Mexico 

Carolyn Lofgren

Acting Director Liaison Services

Indian Health Service

Albuquerque, New Mexico

Lois Grey Long, R.N., M.S.N.

Albuquerque, New Mexico 

Katherine Magruder, Ph.D.

Director

Office of Rural Mental Health Research

Acting Chief, Services Research Branch

Division of Epidemiology and Services Research

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland 

Jack D. Maser, Ph.D.

Chief

Anxiety and Somatoform Disorders Program

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland 

Susan Mattson, Ph.D., R.N.C.

Associate Professor

College of Nursing

Arizona State University

Scottsdale, Arizona 

Vickie M. Mays, Ph.D.

Professor and Director

University of California, Los Angeles

Department of Psychology

Los Angeles, California 

Barbara McLaughlin, Ph.D.

Professor/Associate Dean for Research

University of Louisville School of Medicine

Kentucky Lions Eye Center

Louisville, Kentucky 

Martha A. Medrano, M.D., M.P.H.

Associate Director

UTHSCSA-Medical Hispanic COE

San Antonio, Texas 

Nancy Milliken, M.D.

University of California

San Francisco Medical Center

San Francisco, California 

Nancy Moss, Ph.D.

Deputy Director

Northern California Cancer Center

Union City, California 
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VOLUME2

Lawrence M. Nelson, M.D.

Staff Scientist and Senior Surgeon

Section on Women’s Health, DEB

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland 

Marcia G. Ory, Ph.D., M.P.H.

Chief

Social Science Research on Aging

Behavioral and Social Research Program

National Institute on Aging

Bethesda, Maryland 

Barbara Overman, Ph.D.

Director

Nurse-Midwifery Program

College of Nursing

University of New Mexico

Albuquerque, New Mexico

Electra D. Paskett, Ph.D.

Associate Professor

Bowman Gray School of Medicine Wake-Forest University

Winston-Salem, North Carolina

Kathleen Pittman, D.S.N., R.N.C., P.N.P.

Assistant Professor

Emory University School of Nursing

Atlanta, Georgia Vivian W. Pinn, M.D.

Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland 

Ellyn J. Pollack, M.A., APR

Information Officer

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Amelie G. Ramirez, Dr.P.H.

Associate Professor of Medicine

Associate Director

Center for Cancer Control Research

Baylor College of Medicine

Houston, Texas

Rebeca Ramos, M.P.H., M.A.

Director Training and Technical Assistant

U.S.-Mexico Border Health Association

El Paso, Texas 

Joan Y. Reede, M.D., M.P.H., M.S.

Assistant Dean

Faculty Development and Diversity

Minority Faculty Development Program 

Harvard Medical School 

Boston, Massachusetts 

Karen Renick, M.Arch.

Board Member

DES Action

Austin, Texas 

Diana H. Rintala, Ph.D.

Associate Professor

Department of Physical Medicine and Rehabilitation

Co-director of Research and Training on Community 

Integration for Individuals With Spinal Cord Injury

Baylor College of Medicine 

Houston, Texas 

Peggy Roberts, M.D.

Family Physician

Albuquerque, New Mexico 

Helen Rodriguez-Trias, M.D.

Co-Director

Pacific Institute for Women’s Health Western Consortium for Public Health

Los Angeles, California

Adele Roman, M.S.N.

Deputy Women’s Health Coordinator

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland 

Paul Roth, M.D.

Dean

University of New Mexico School of Medicine

Health Sciences Center

Albuquerque, New Mexico 

Joyce Rudick

Acting Deputy Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Dawn Sanchez, M.B.A.

MCH Planner

New Mexico Border Health Office

Las Cruces, New Mexico 

Gloria Sarto, M.D., Ph.D.

Professor and Chairperson

Department of Obstetrics and Gynecology

University of New Mexico

Albuquerque, New Mexico

Elizabeth Schubert, Ph.D.

Division of Medical Genetics

University of Washington

Seattle, Washington

Janet Scott-Harris

Regional Program Consultant

Department of Health and Human Services

Office of Minority Health

Boston, Massachusetts 

Belinda Seto, Ph.D.

Senior Advisor

Office of Extramural Research

National Institutes of Health

Bethesda, Maryland

Robin Seydel

Action for Women’s Health

Albuquerque, New Mexico

Audrey Sheppard

Acting Director

Office of Women’s Health

Food and Drug Administration

Rockville, Maryland 

Catherine Sherif, M.D.

Institute for Women’s Health

Philadelphia, Pennsylvania 

Eleanor Shore, M.D., M.P.H.

Dean for Faculty Affairs

Harvard Medical School

Boston, Massachusetts 

Deborah Shrag, M.D.

Instructor in Medicine

Dana Farber Cancer Institute

Boston, Massachusetts

Susan F. Silverton, M.D., Ph.D.

AADS Enid Neidle Fellow

University of Pennsylvania

Philadelphia, Pennsylvania 

Anne R. Simpson, M.D.

Fellow-Gerontology/Internal Medicine

University of New Mexico Health Science Center

Albuquerque, New Mexico

Linda C. Skidmore, M.S.

Director

Committee on Women in Science and Engineering

National Research Council

National Academy of Sciences

Washington, District of Columbia

Stephanie Smith, M.S.

Department of Preventive Medicine

Division of Medical Genetics

University of Mississippi School of Medicine

Jackson, Mississippi

Lauren Spitz, M.P.A./HA

Research Analyst

Oregon Health Division

Portland, Oregon 

Anne Stansell

State Director-Support Group Leader

United Silicone Survivors of the World

Los Lunas, New Mexico 

Carolyn Stern, M.D.

Family Practice Center

Park Ridge, Illinois 

Lisa Cacari Stone, M.S., L.M.F.T.

Healthier Communities

Department of Health, Public Health Division

Santa Fe, New Mexico 

Deborah Studen-Pavlovich, D.M.D.

Associate Professor

Director, Predoctoral Pediatric Dentistry

Department of Pediatric Dentistry

University of Pittsburgh

Pittsburgh, Pennsylvania 

Anne E. Summer, M.D.

Assistant Professor

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania 
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VOLUME 2

Norma Swenson, M.Ph.

Newton Center, Massachusetts 

JoAnn M. Thierry, M.S., M.S.W.

Public Health Advisor

Centers for Disease Control and Prevention

Office on Disability and Health

Atlanta, Georgia 

Nancy Thomann, M.P.H.

Regional Minority and Women’s Health Consultant

U.S. Public Health Service, Region VIII

Denver, Colorado 

Cecilia Tillez

Senior Medical Student 

Albuquerque, New Mexico 

Lillian Tom-Orme, Ph.D., M.P.H, M.S.

Faculty

Huntsman Cancer Institute

Division of Public Health Sciences

Salt Lake City, Utah 

Eliseo “Cheo” Torres, Ph.D.

Vice President for Student Affairs

University of New Mexico

Albuquerque, New Mexico

Laura Tosi, M.D.

Associate Professor of Orthopaedic Surgery (Pediatrics)

George Washington University School of Medicine

Children’s National Medical Center 

Washington, District of Columbia

Justina A. Trott, M.D.

Medical Director Women’s Health Services 

Santa Fe, New Mexico 

Patricia Urbanski, R.N., M.S.N, C.C.E., L.C.S.

Chair

New Mexico Section

Association of Women’s Health, Obstetrics 

and Neonatal Nurse 

Washington, District of Columbia

Wulf H. Utian, M.D., Ph.D.

Professor and Chairman

University MacDonald Women’s Hospital 

Chairman of Reproductive Biology 

Case Western Reserve University 

Cleveland, Ohio 

Katherine Wallman

Chief Statistician

Statistical Policy Office

Office of Management and Budget

Washington, District of Columbia

Barbara L. Weber, M.D.

Associate Professor of Medicine and Genetics

Director, Breast Cancer Program

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania

Anita Corman Weinblatt, Ph.D.

Scientific Review Administrator

Division of Research Grants

National Institutes of Health

Bethesda, Maryland 

Sandra Welner, M.D.

Primary Care Gynecology for Disabled Women

Silver Spring, Maryland 

Sheila West, Ph.D.

Professor

Johns Hopkins University Hospital

Baltimore, Maryland 

Christine M. Wilson

Vice President

Communications and Strategic Planning

Fox Chase Cancer Center

Philadelphia, Pennsylvania 

Barbara W.K. Yee, Ph.D.

Associate Professor

Department of Health Promotion and Gerontology

School of Allied Health Sciences

University of Texas Medical Branch

Galveston, Texas

Caroline Yu, M.P.A.

Regional Coordinator, New York

National Asian Women’s Health Organization

San Francisco, California 

Carmen Zorilla, M.D.

Department of Obstetrics and Gynecology

University of Puerto Rico School of Medicine

San Juan, Puerto Rico 

Diana Zuckerman, Ph.D.

Director of Research and Policy Analysis

Institute for Women’s Policy Research

Member of Board of Directors

National Women’s Health Network 

Washington, District of Columbia

Putting It All Together: The Agenda for Research on Women’s Health for the 21st Century

Bethesda Marriott

Bethesda, Maryland

November 17-19, 1997

AGENDA

MONDAY, NOVEMBER 17, 1997

11:00 a.m.-7:00 p.m. Conference Registration

PUBLIC HEARING

1:00-6:00 p.m. Public Testimony: The Women’s Health Task Force Research Agenda for the 21st Century

TUESDAY, NOVEMBER 18, 1997

SCIENTIFIC WORKSHOP DAY 1

7:00 a.m.-6:30 p.m. Conference Registration

7:00-8:00 a.m. Continental Breakfast

8:00 a.m.-12:00 p.m. Opening Plenary Session

8:00-9:00 a.m. Welcome and Opening Remarks

Vivian W. Pinn, M.D.

Ruth L. Kirschstein, M.D.

Remarks 

The Honorable Barbara A. Mikulski, U.S. Senate

The Honorable Constance A. Morella, U.S. House of Representatives

9:00-9:30 a.m. Overview: Beyond Hunt Valley: Research on Women’s Health for the 21st Century

Vivian W. Pinn, M.D.

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BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH

FOR THE 21 S T CENTURY
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

9:45-10:00 a.m. Break

10:00-11:00 a.m. Scientific Plenary Session I

Genetics, Genomics, and Women’s Health

Francis Collins, M.D., Ph.D.

Director, NHGRI

Panel Discussion: Legal and Ethical Issues 

Karen Rothenberg, J.D.

John Fletcher, Ph.D.

Robert Murray, Ph.D.

11:00-11:45 a.m. Scientific Plenary Session II

Heart Disease Research in Women: A Look Back and a View to the Future

Claude Lenfant, M.D., Director, NHLBI

Remarks: Research on Women: An Investigator’s View

Julie Buring, Sc.D.

Charge to the Working Groups

Donna Dean, Ph.D.

Marianne Legato, M.D.

12:00-1:15 p.m. Lunch

Speaker: The Cancer Program at the End of the 20th Century

Richard Klausner, M.D., Director, NCI

1:30-4:15 p.m. Breakout to Working Groups

Alcohol and Other Drug Use Disorders and Consequences 

Bone and Musculoskeletal Disorders

Cancer

Cardiovascular and Pulmonary Disease

Career Issues for Women Scientists

Digestive Diseases

Immunity and Autoimmune Diseases

Mental Disorders

Neuroscience

Oral Health

Pharmacology

Reproductive Issues

Urologic and Kidney Conditions

4:30-6:00 p.m. Scientific Plenary Session III

Panel Discussion: Women’s Health Research 

Women and Research: Quo Vadis? 

Antonia C. Novello, M.D., M.P.H.
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VOLUME 2

Beyond Hunt Valley: Perspectives 

Maureen Henderson, M.D., M.P.H.

Implications for Education and Public Policy

Barbara Ross-Lee, D.O.

Remarks 

Audrey T. Haynes, Deputy Assistant to the President

White House Office for Women’s Initiatives and Outreach

6:00-7:30 p.m. Networking Reception

The Honorable Louise M. Slaughter, U.S. House of Representatives

WEDNESDAY, NOVEMBER 19, 1997

SCIENTIFIC WORKSHOP DAY 2

7:00-8:00 a.m. Continental Breakfast

8:00-9:00 a.m. Scientific Plenary Session IV

Speaker: Women in Biomedical Careers

Lydia Villa-Kamaroff, Ph.D.

Remarks: Women in Health — Towards a New Paradigm

Margaret Chesney, Ph.D.

9:00 a.m.-12:00 p.m. Concurrent Working Groups (continue)

12:00 p.m. Lunch

Remarks

The Honorable Louis Stokes, U.S. House of Representatives

Speaker: Putting It All Together

Byllye Avery, M.Ed.

1:15-3:00 p.m. Closing Plenary Session

Working Group Reports

Working Group Cochairs

Task Force Cochairs

Discussion

Closing Remarks/Adjournment

Task Force Cochairs

Vivian W. Pinn, M.D.

3:15 p.m. Press Briefing
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A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Katherine Alley, M.D.

Betty Ford Comprehensive Breast Center

George Washington University Hospital

Columbia Hospital for Women

Washington, District of Columbia

Amy Allina

Reproductive Health Technologies Project

Washington, District of Columbia

Gail D. Anderson, Ph.D.

Department of Pharmacy and Pharmaceutics

School of Pharmacy

University of Washington

Seattle, Washington

Margaret Anderson, M.A.

Society for the Advancement of Women’s 

Health Research

Washington, District of Columbia

Ruth A. Anderson, D.D.S.

College of Dentistry

Howard University

Washington, District of Columbia

Marietta Anthony, Ph.D.

Office of Women’s Health

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Karen Antman, M.D.

Division of Medical Oncology

Columbia University College of Physicians 

and Surgeons

New York, New York

Juanita A. Archer, M.D.

Endocrine/Metabolic Section

Department of Internal Medicine

Howard University Hospital

Washington, District of Columbia

BEYOND HUNT VALLEY: 

RESEARCH ON WOMEN’S HEALTH FOR THE 21st CENTURY

BETHESDA, MARYLAND

NOVEMBER 17-19, 1997

PARTICIPANTS

Joan Abell 

Information, Resources, and Inquiries Branch

Office of Scientific Information

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Diane L. Adams, M.D., M.P.H.

Center for Information Technology

Agency for Health Care Policy and Research

Rockville, Maryland

Lucile Adams-Campbell, Ph.D.

Howard University Cancer Center

Washington, District of Columbia

Megan Adamson, M.D.

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

Bethesda, Maryland

Dyanne D. Affonso, Ph.D., F.A.A.N.

Nell Hodgson Woodruff School of Nursing

Emory University

Atlanta, Georgia

Kathy S. Albain, M.D.

Division of Hematology/Oncology

Loyola University Medical Center

Maywood, Illinois

Michael Albo, M.D.

Division of Urology

University of California, San Diego

San Diego, California

Marjorie J. Albohm, M.S., A.T.C.

Research and Education Foundation

National Athletic Trainers Association

Mooresville, Indiana
517

VOLUME2

Lynn Armentrout

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Carol A. Aschenbrener, M.D.

Kaludis Consulting Group Washington, District of Columbia

Kathryn Atchison, D.D.S., M.P.H.

School of Dentistry

University of California

Los Angeles, California

Constance W. Atwell, Ph.D.

Division of Extramural Activities

National Institute of Neurological Disorders 

and Stroke

National Institutes of Health

Bethesda, Maryland

Phyllis August, M.D.

Division of Hypertension

New York Hospital

Cornell University

New York, New York

Faye C. Austin, Ph.D.

Division of Cancer Biology

National Cancer Institute

National Institutes of Health

Rockville, Maryland

Byllye Avery, M.Ed.

National Black Women’s Health Project

Swarthmore, Pennsylvania

James Baker, M.D.

Division of Allergy

University of Michigan

Ann Arbor, Michigan Winnie Barouch, Ph.D.

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Steve Barrett

USA Weekend

Arlington, Virginia

Barbara Bartman, M.D.

University of Maryland School of Medicine

Baltimore, Maryland

Anne R. Bavier, M.N., F.A.A.N.

Nell Hodgson Woodruff School of Nursing

Emory University

Atlanta, Georgia

Marcia Bayne-Smith, D.S.W., A.C.S.W.

Urban Studies Department

Queen’s College

City University of New York

Flushing, New York

Lula A. Beatty, Ph.D.

Special Populations Office

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland

Jill B. Becker, Ph.D.

Department of Psychology

Biopsychology Area

University of Michigan

Ann Arbor, Michigan

Kevin G. Becker, Ph.D.

National Human Genome Research Institute

National Institutes of Health

Bethesda, Maryland

Julie Beitz, M.D.

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Praxedes V. Belandres, M.D.

Physical Medicine and Rehabilitation/ Telemedicine Evaluation

Army Operational Medicine Research Program

U.S. Army Medical Research and Materiel Command

Frederick, Maryland

Frank Bellino, Ph.D.

Biology and Aging Program

National Institute on Aging

National Institutes of Health

Bethesda, Maryland

Adrianne Bendich, Ph.D.

Roche Vitamins, Inc.

Parsippany, New Jersey

Alison W. Bennett

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland
518

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Kate Berg, Ph.D.

Section on Ethics and Special Populations

National Human Genome Research Institute

National Institutes of Health

Bethesda, Maryland

Mary J. Berg, Pharm.D.

Division of Clinical and Administrative Pharmacy

College of Pharmacy

University of Iowa

Iowa City, Iowa

Karen Berkley, Ph.D.

Program in Neuroscience

Florida State University

Tallahassee, Florida

Michelle Berlin, M.D., M.P.H.

University of Pennsylvania

Philadelphia, Pennsylvania

Roberta Biegel, M.A.

Society for the Advancement of Women’s 

Health Research

Washington, District of Columbia

Marsha Judy Bievre, B.A.

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Roberta Binder, Ph.D.

Sexually Transmitted Disease Branch

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Rockville, Maryland

Stephanie J. Bird, Ph.D.

Massachusetts Institute of Technology

Cambridge, Massachusetts

Shirley Blakely

Food and Drug Administration

Department of Health and Human Services

Washington, District of Columbia

Mary Blehar, Ph.D.

Schizophrenia, Mood, and Other Brain Disorders

Behavioral Research and AIDS

Division of Mental Disorders

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Linda Burnes Bolton, Ph.D., R.N., F.A.A.N.

National Black Nursing Association

Los Angeles, California

Elizabeth Borda

Women and Epilepsy Initiative

Epilepsy Foundation

Landover, Maryland

Lisa Bowleg, Ph.D.

Center for Women Policy Studies

Washington, District of Columbia

Lori A. Boyajian, D.O.

College of Osteopathic Medicine

The University of Health Sciences

Kansas City, Missouri

Barbara Boyan, Ph.D.

Department of Orthopaedics

The University of Texas Health Sciences Center

San Antonio, Texas

Margaret Brackley, Ph.D., R.N.

School of Nursing-Family Nursing Care

University of Texas Health Science Center

San Antonio, Texas

Hannah Bradford

Society for Acupuncture Research

Bethesda, Maryland

Edward N. Brandt, Jr., M.D., Ph.D.

Center for Health Policy Research

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma

Irene Brandt

Eli Lilly and Company

Washington, District of Columbia

Otis W. Brawley, M.D.

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Joel O. Brende, M.D.

Mercer University School of Medicine

Macon, Georgia

Maxine Brinkman

Director of Women’s Services

The National Association of Professionals 

in Women’s Health

Chicago, Illinois
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VOLUME 2

Joyce Briscoe

American Academy of Orthopaedic Surgeons

Washington, District of Columbia

Evelyn Bromet, Ph.D.

Sjögren’s Syndrome Foundation, Inc.

Jericho, New York

Sandra Brooks, M.D.

Society of Gynecologic Oncologists

Washington, District of Columbia

David M. Brown, M.D.

School of Medicine

University of Minnesota

Minneapolis, Minnesota

Michael A. Brown, M.P.H.

Office of Women’s Health

Centers for Disease Control and Prevention

Atlanta, Georgia

Allyson Browne

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Ross C. Brownson, Ph.D.

St. Louis University School of Public Health

St. Louis, Missouri

George Bryan, M.D.

School of Medicine

University of Texas Medical Branch

Galveston, Texas

Patricia S. Bryant, Ph.D.

Behavior, Health Promotion, and Environment Program

Division of Extramural Research

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Ruth Ellyn Bulger, Ph.D.

Uniformed Services University of the Health Sciences

Bethesda, Maryland

Jonca Bull, M.D.

Office of Operations

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Richard C. Bump, M.D.

Department of Obstetrics/Gynecology

Duke University Medical Center

Durham, North Carolina

Linda Burhansstipanov, Dr.P.H., M.S.P.H.

AMC Native American Cancer Research Center

Denver, Colorado

Julie E. Buring, Sc.D.

Brigham and Women’s Hospital

Boston, Massachusetts

Constance Burr

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Virginia S. Cain, Ph.D.

Office of Behavioral and Social Sciences Research

Office of the Director

National Institutes of Health

Bethesda, Maryland

Francisco Calvo, Ph.D.

Special Emphasis Panel Section, Review Branch

National Institute of Diabetes and Digestive 

and Kidney Diseases

National Institutes of Health

Bethesda, Maryland

Michael Camilleri, M.D.

Gastro Intestinal Unit

Mayo Clinic

Rochester, Minnesota

Jacquelyn C. Campbell, Ph.D., R.N., F.A.A.N.

School of Nursing

The Johns Hopkins University

Baltimore, Maryland

Gena Carter, M.D.

American Cancer Society

Jamaica Plain, Maine

Constance Cashen

St. Vincent Hospital

Toledo, Ohio

John Caughron, M.D.

Uniformed Services

University of Health Sciences

Washington, District of Columbia
520

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Kennerly Chapman

Office of Women’s Health

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Molly S. Chatterjee, M.D.

Maternal-Fetal Medicine

Meharry Medical College

Brentwood, Tennessee

Margaret A. Chesney, Ph.D.

University of California, San Francisco

San Francisco, California

Freda K. Cheung, Ph.D.

University of California, Los Angeles

Torrance, California

Geoffrey Cheung, Ph.D.

Office of Alternative Medicine

National Institutes of Health

Bethesda, Maryland

Mary Ellen Cheung, Ph.D.

Division of Stroke, Trauma, and 

Neurodegenerative Disorders

National Institute of Neurological Disorders 

and Stroke

National Institutes of Health

Bethesda, Maryland

Margaret M.L. Chu, Ph.D.

U.S. Environmental Protection Agency

Washington, District of Columbia

Mary Chung

National Asian Women’s Health Organization

San Francisco, California

Mary T. Chunko, M.A.

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Dorothy Cirelli

Patient Recruitment and Referral Center

Warren Grant Magnuson Clinical Center

National Institutes of Health

Bethesda, Maryland

Alice Clark, Ph.D.

Office of the Director

School of Pharmacy

National Center for the Development of 

Natural Products

The University of Mississippi

University, Mississippi

Pamela A. Clax, D.P.M.

Treatment Research Program

Division of Acquired Immunodeficiency Syndrome

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Rockville, Maryland

Curt S. Clifton

Congressman Albert Wynn’s Office

Washington, District of Columbia

Kathleen Clouse, M.D.

Center for Biologics Evaluation and Research

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Nora Cody, M.A.

DES Action, USA

Oakland, California

Ervin Jean Coleman, M.S.

National Black Nurses Association

Tyler, Texas

Elaine Collier, M.D.

Autoimmunity Section

Division of Allergy, Immunology, and Transplantation

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

Francis S. Collins, M.D., Ph.D.

National Human Genome Research Institute

National Institutes of Health

Bethesda, Maryland

Karen Scott Collins, M.D., M.P.H.

The Commonwealth Fund

New York, New York

J.C. Comolli, M.B.A., R.N.

Office on AIDS

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland
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VOLUME 2

Leah Conn, B.A.

Public Responsibility in Medicine and Research

Boston, Massachusetts

Alice H. Conti, M.B.A.

Wyeth-Ayerst Laboratories

Philadelphia, Pennsylvania

Bente E. Cooney, M.S.W.

National Osteoporosis Foundation

Washington, District of Columbia

Judith A. Cooper, Ph.D.

Division of Human Communication

National Institute on Deafness and Other 

Communication Disorders

National Institutes of Health

Bethesda, Maryland

Zara Cooper, B.S.

Mount Sinai School of Medicine

New York, New York

Susan Coren

Washington, District of Columbia

Kathleen Costigan, R.N., M.P.H.

Johns Hopkins Hospital

Baltimore, Maryland

Terrie Cowley, B.A.

The T.M.J. Association, Ltd.

Elm Grove, Wisconsin

Kathy Croft, M.A.

Association of American Medical Colleges

Washington, District of Columbia

C. Deborah Cross, M.D.

Committee on Women

Albany Medical School

American Psychiatric Association

Albany, New York

Nancy Boucat Cummings, M.D.

National Institute of Diabetes and Digestive 

and Kidney Diseases

National Institutes of Health

Bethesda, Maryland

Frances Cuomo, M.D.

Hospital for Joint Diseases

New York, New York

Gary Curhan, M.D., Sc.D.

Channing Laboratory

Brigham and Women’s Hospital

Boston, Massachusetts

Katy Curran, M.S., A.T.C.

Conde Nast Sports for Women

Atlanta, Georgia

Jaleh Daie, Ph.D.

University of Wisconsin at Madison

Madison, Wisconsin

Alice J. Dan, Ph.D.

Center for Research on Women and Gender

University of Illinois at Chicago

Chicago, Illinois

Jacqueline E. Darroch, Ph.D.

The Alan Guttmacher Institute

New York, New York

Robin Davis, M.D.

Breast Cancer Resource Committee

Baltimore, Maryland

Sahar Dawisha, M.D.

Center for Devices and Radiological Health

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Harriet de Wit, Ph.D.

Department of Psychiatry

University of Chicago

Chicago, Illinois

Donna Dean, Ph.D.

Division of Physiological Systems

Center for Scientific Review

National Institutes of Health

Bethesda, Maryland

Betty Diamond, M.D.

Immunology and Microbiology and Medicine

Albert Einstein College of Medicine

Yeshiva University

Bronx, New York

Leah J. Dickstein, M.D.

Department of Psychiatry

University of Louisville School of Medicine

Louisville, Kentucky
522

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Catherine Didion, A.B.

Association for Women in Science

Washington, District of Columbia

Anna Mae Diehl, M.D.

Johns Hopkins University School of Medicine

Baltimore, Maryland

Bobbie Dill, R.N., B.S.N.

Behavioral Medicine Solutions of Virginia

Roanoke, Virginia

James Dill, M.D.

Internal Medicine

Endoscopic Ultrasound of Virginia

Roanoke, Virginia

Mercer University

Macon, Georgia

Deborah I. Dingell

GM Foundation

Washington, District of Columbia

Karen M. Dodge

Substance Abuse and Mental Health 

Services Administration

Department of Health and Human Services

Rockville, Maryland

Alicia Doherty

R.O.W. Sciences, Inc.

Rockville, Maryland

Joanne Donovan, M.D., Ph.D.

Gastroenterology Section

Department of Medicine

West Roxbury Veterans Administration 

Medical Center

West Roxbury, Massachusetts

Mark Donowitz, M.D.

G-I Division

Johns Hopkins University School of Medicine

Baltimore, Maryland

Betty Dooley

Women’s Research and Education Institute

Washington, District of Columbia

Leilani Doty, Ph.D.

Department of Neurology

University of Florida College of Medicine

Gainesville, Florida

Yvette Drake, B.S.

Silver Spring, Maryland

Carolyn M. Dresler, M.D.

Fox Chase Cancer Center

American College of Chest Physicians

Philadelphia, Pennsylvania

Barbara Drinkwater, Ph.D.

Pacific Medical Center

Seattle, Washington

Therese M. Droste

Reuters Health

Washington, District of Columbia

Mary C. Dufour, M.D., M.P.H.

National Institute on Alcohol Abuse 

and Alcoholism

National Institutes of Health

Bethesda, Maryland

Carolyn P. Dukarm, M.D.

University of Rochester

Rochester, New York

Marilyn Duncan, M.D.

Pediatric Oncology Program

Department of Pediatrics

Health Sciences Center

School of Medicine

University of New Mexico

Albuquerque, New Mexico

Jane Durken, B.S.N., R.N.

Adventist Healthcare

Rockville, Maryland

Debra Egan, M.P.H.

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Carola Eisenberg, M.D.

Harvard Medical School

Cambridge, Massachusetts

Margery Elfin, Ph.D.

Department of Political Science

Hood College

Washington, District of Columbia
523

VOLUME 2

Sherman Elias, M.D.

Department of Obstetrics/Gynecology

Baylor College of Medicine

Houston, Texas

Linda Elkins, Ph.D.

Hoechst Marion Roussel, Inc.

Kansas City, Missouri

Susan Epstein, M.S., M.Ed.

Center for Women with Disability

Western New York Neuroscience Center

Buffalo General Hospital

Buffalo, New York

Deborah Erickson, M.D.

Section of Urology

Pennsylvania State University College of Medicine

Hershey, Pennsylvania

Sumru Erkut, Ph.D.

Center for Research for Women

Wellesley College

Wellesley, Massachusetts

Sandra Estepa, M.S.

U.S. Public Health Service Office on Women’s Health

New York, New York

John J. Estrada, M.D.

Department of Pediatrics

Meharry Medical College

Nashville, Tennessee

Suzette Evans, Ph.D.

Research Foundation for Mental Hygiene

New York, New York

Christine Everett

Office of Women’s Health

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Jay Everhart, M.D., M.P.H.

Epidemiology and Clinical Trials Branch

National Institute of Diabetes and Digestive 

and Kidney Diseases

National Institutes of Health

Bethesda, Maryland

Bonita Falkner, M.D.

Institute for Women’s Health

Allegheny University of Health Sciences

Philadelphia, Pennsylvania

Odom Fanning

Internal Medicine World Report

Bethesda, Maryland

Susan Farrell

National Institute on Alcohol Abuse 

and Alcoholism

National Institutes of Health

Bethesda, Maryland

Susan Farrer

The MayaTech Corporation

Silver Spring, Maryland

Stephen L. Farrow, M.D.

John Dingel Virginia Medical Center

4H University Health Center

Wayne State University School of Medicine

Detroit, Michigan

Denise L. Faustman, M.D., Ph.D.

Immunobiology Laboratory

Medicine/Diabetes Unit

Massachusetts General Hospital

Charlestown, Massachusetts

Gayle Feldman, M.Sc., M.A.

Self Magazine

New York, New York

Diane Felsen, Ph.D.

Department of Urology

Cornell Medical School

New York, New York

Maria Figueroa, M.A., M.B.A.

The Marin Group

Arlington, Virginia

Patricia Finn, M.D.

Respiratory Division

Brigham and Women’s Hospital

Boston, Massachusetts

Loretta P. Finnegan, M.D.

Community Prevention Study

Community Outreach

National Institutes of Health

Bethesda, Maryland

Kate Fiore

The Cancer Letter

Washington, District of Columbia
524

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Polly A. Fitz, M.A., R.D.

The American Dietetic Association

Chicago, Illinois

Jack Fitzsimmons, M.D., M.B.A.

Office of Women’s Health

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Laura Flawn, M.D.

Austin Orthopaedic Clinic

Austin, Texas

John C. Fletcher, Ph.D.

Biomedical Ethics

University of Virginia

Keswick, Virginia

Marie Foegh, M.D., D.Sc.

Department of Surgery

Georgetown University Medical Center

Washington, District of Columbia

Janet Heald Forlini, J.D.

Center to Improve Care of the Dying

Washington, District of Columbia

Jean Fourcroy, M.D., Ph.D.

American Medical Women’s Association

Bethesda, Maryland

Philip C. Fox, D.D.S.

Division of Intramural Research

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Tracy Fox, M.P.H., R.D.

The American Dietetic Association

Washington, District of Columbia

Betsy Foxman, Ph.D.

Department of Epidemiology

University of Michigan

Ann Arbor, Michigan

Erica Frank, M.D., M.P.H.

Women Physicians’ Health Study

Department of Family Medicine and 

Preventive Medicine

Robert W. Woodruff Health Sciences Center

Emory University School of Medicine

Atlanta, Georgia

Patricia Frasier, M.D.

Brigham and Women’s Hospital

Boston, Massachusetts

Marilynn Frederiksen, M.D.

General Obstetrics/Gynecology

Northwestern University Medical School

Chicago, Illinois

Shu Man Fu, M.D.

Department of Internal Medicine

University of Virginia Health Sciences Center

Charlottesville, Virginia

Bruce Fuchs, Ph.D.

Office of Science Education

Office of the Director

National Institutes of Health

Rockville, Maryland

Sheryle Gallant, Ph.D.

Department of Psychology

University of Kansas

Lawrence, Kansas

Elaine Gallin, Ph.D.

State University of New York Health 

Science Center – Brooklyn

Brooklyn, New York

Michele Garber, M.P.H., C.H.E.S.

Gaithersburg, Maryland

Neal Garrett, Ph.D.

School of Dentistry

University of California, Los Angeles

Los Angeles, California

Francisco Garrido, M.D.

National Institute of Public Health

Cuernavaca, Morelos

Mexico

Judith S. Gavaler, Ph.D.

Women’s Health Research Program

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma

Robert W. Gear, D.D.S., Ph.D.

Department of Restorative Dentistry

University of California

San Francisco, California
525

VOLUME 2

Lynn H. Gerber, M.D.

Rehabilitation Medicine Department

Clinical Center

National Institutes of Health

Bethesda, Maryland

Mary B. Gerwin, J.D.

Government Relations

American Gastroenterological Association

Bethesda, Maryland

Elizabeth Gibbens

Community Development Publications

Silver Spring, Maryland

Linda C. Giudice, M.D., Ph.D.

Division of Reproductive Endocrinology and Infertility

Department of Obstetrics/Gynecology

Stanford University Medical Center

Stanford, California

Hannah Gladfelter

Health Grants and Contracts Weekly

Capitol Publications

Alexandria, Virginia

W. Lou Glasse, M.S.W.

Older Women’s League

Vassar College

Poughkeepsie, New York

Irma E. Goertzen

Magee-Women’s Hospital

Pittsburgh, Pennsylvania

Robert Goldenberg, M.D.

Intramural Research Programs

National Institute of Mental Health

National Institutes of Health

Birmingham, Alabama

Marlene B. Goldman, Sc.D.

Department of Epidemiology

Harvard School of Public Health

Boston, Massachusetts

Jill M. Goldstein, Ph.D.

Department of Psychiatry

Harvard Institute for Psychiatric Epidemiology 

and Genetics

Massachusetts Mental Health Center

Harvard Medical School

Boston, Massachusetts

Edith S.L. Gomberg, Ph.D.

Department of Psychiatry

Alcohol Research Center

University of Michigan School of Medicine

Ann Arbor, Michigan

Sandra Goodbody, M.S.W.

Washington, District of Columbia

Eileen G. Gorman, Ph.D.

Wilmington, Delaware

Julie Graber, Ph.D.

Adolescent Study Program

Teachers University

Columbia University

New York, New York

Patricia A. Grady, Ph.D., R.N.

National Institute of Nursing Research

National Institutes of Health

Bethesda, Maryland

Julie Fleming Graham, M.Ed.

Ogelthorpe County School System

Lexington, Georgia

Norman F. Grant, Jr., M.D.

American Board of Obstetrics and Gynecology, Inc.

Dallas, Texas

Gilman D. Grave, M.D.

Endocrinology, Nutrition, and Growth Branch

Center for Research for Mothers and Children

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Paulette S. Gray, Ph.D.

Division of Extramural Activities

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Phyllis Greenberger, M.S.W.

Society for the Advancement of Women’s 

Health Research

Washington, District of Columbia

John C. Greene, D.M.D., M.P.H.

School of Dentistry

University of California, San Francisco

San Rafael, California
526

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Letha Y. Griffin, M.D.

American Orthopaedic Society for Sports Medicine

Atlanta, Georgia

Jeane Ann Grisso, M.D., M.Sc.

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania

Andrew A. Guccione, Ph.D., P.T.

American Physical Therapy Association

Alexandria, Virginia

Racquel Gur, M.D., Ph.D.

Connecticut Mental Health Center

New Haven, Connecticut

Judith K. Gwathmey, U.M.D., Ph.D.

Institute for Cardiovascular Diseases and 

Muscle Research Inc.

Boston University

Cambridge, Massachusetts

Uriel Halbreich, M.D.

Biobehavioral Program

SUNY Clinical Center

State University of New York at Buffalo

Buffalo, New York

Shirley Haley, M.A.

Washington Fax

South Dartmouth, Massachusetts

Lannis Hall-Daniels, M.D., M.P.H.

St. Louis, Missouri

Betty B. Hambleton

Health Resources and Services Administration

Department of Health and Human Services

Rockville, Maryland

Meg Haney, Ph.D.

Columbia University

New York, New York

Eleanor Z. Hanna, Ph.D.

Division of Biometry and Epidemiology

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

Bethesda, Maryland

Jo A. Hannafin, M.D., Ph.D.

Hospital for Special Surgery

New York, New York

Leslie Hardy, M.H.S.

Office of Health Policy

Office of the Assistant Secretary for Policy 

and Evaluation

Office of the Secretary

Department of Health and Human Services

Washington, District of Columbia

William R. Harlan, M.D.

Disease Prevention

Office of the Director

National Institutes of Health

Bethesda, Maryland

Hazel J. Harper, D.D.S., M.P.H.

Hazel Harper and Associates

Washington, District of Columbia

Barbara Harrison, M.Sc.

National Institute of Diabetes and Digestive 

and Kidney Diseases

National Institutes of Health

Bethesda, Maryland

Florence P. Haseltine, M.D., Ph.D.

Center for Population Research

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Dorothy Hatsukami, Ph.D.

University of Minnesota

Minneapolis, Minnesota

Steven J. Hausman, M.D.

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases

National Institutes of Health

Bethesda, Maryland

Betty Lee Hawks, M.A.

Office of Minority Health

Office of Public Health and Science

Office of the Secretary

Department of Health and Human Services

Rockville, Maryland

Audrey Tayse Haynes, M.A.

Office for Women’s Initiatives and Outreach

Washington, District of Columbia
527

VOLUME2

Suzanne G. Haynes, Ph.D.

Office of Women’s Health

Office of Public Health and Science

Office of the Secretary

Department of Health and Human Services Washington, District of Columbia

Eugene G. Hayunga, Ph.D.

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Janyce N. Hedetniemi, M.S.

Office of Community Liaison

Office of the Director

National Institutes of Health

Bethesda, Maryland

Cassandra E. Henderson, M.D.

Albert Einstein College of Medicine

Bronx, New York

Maureen Henderson, M.D., Dr.P.H.

Fred Hutchinson Cancer Research Center

University of Washington

Seattle, Washington

Susan L. Hendrix, D.O.

Hutzel Hospital Wayne State University

Detroit, Michigan

Deborah B. Henken, Ph.D.

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Janet Henrich, M.D. Yale University School of Medicine

New Haven, Connecticut

Jean Henry, B.S., M.A., Ph.D.

Center for Research on Women’s Health Texas Woman’s University

Denton, Texas

Mary Hepburn, B.S.

North Platte, Nebraska

Arthur L. Herbst, M.D.

Department of Obstetrics/Gynecology

University of Chicago

Chicago, Illinois

Milton J. Hernandez, Ph.D.

Office of Science Training

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

A. Regula Herzog, Ph.D.

Survey Research Center

Institute for Social Research

University of Michigan

Ann Arbor, Michigan

Andrew Herzog, M.D., M.Sc.

Neuroendocrine Unit

Beth Israel Deaconess Medical Center

Boston, Massachusetts

Euthymia D. Hibbs, Ph.D.

Division of Services and Intervention Research

Child and Adolescent Treatment and Preventive 

Intervention Research Branch

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Linda C. Hodges, Ph.D.

Atlanta Science Center for Women

Agnes Scott College

Decatur, Georgia

Nicolette Horbach, M.D.

The American Urogynecologic Society

Annandale, Virginia

Michaeleen Howatt-Nab, B.A., M.F.A.

Ohio University College of Osteopathic Medicine

Athens, Ohio

Joanne Howes

Bass and Howes, Inc. Washington, District of Columbia

Judith Hsia, M.D.

George Washington University Washington, District of Columbia

Carole Hudgings, Ph.D.

National Institute of Nursing Research

National Institutes of Health

Bethesda, Maryland

Elmer E. Huerta, M.D., M.P.H.

Cancer Risk Assessment and Screening Center Washington Hospital Center Washington, District of Columbia
528

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Carrie P. Hunter, M.D., M.P.H.

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Chyren Hunter, Ph.D.

National Institute on Deafness and Other 

Communication Disorders

National Institutes of Health

Bethesda, Maryland

Joseph K. Hurd, Jr., M.D.

Department of Gynecology

Lahey Hitchcock Clinic Medical Center

Burlington, Massachusetts

Margaret Huyck, Ph.D.

Office of Behavioral and Social Sciences Research

Office of the Director

National Institutes of Health

Bethesda, Maryland

Mary Lloyd Ireland, M.D.

Ruth Jackson Orthopaedic Society

Lexington, Kentucky

Ann S. Jackson

Giovanni Lorenzini Medical Foundation

Houston, Texas

Debbie M. Jackson, M.A.

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Sharon Jackson, M.D.

Laboratory of Host Defenses

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

Marjorie Kaplan Jeffcoat, D.M.D.

Department of Periodontics

The University of Alabama at Birmingham 

School of Dentistry

Birmingham, Alabama

Kimberly Jeffries-Leonard, Ph.D.

The MayaTech Corporation

Silver Spring, Maryland

Jean Jew, M.D.

Department of Anatomy and Cell Biology

College of Medicine

University of Iowa

Iowa City, Iowa

Katrina Johnson, Ph.D.

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Merrilyn D. Johnson, Ph.D., R.N.

Medical University of South Carolina

Charleston, South Carolina

Tamara Lewis Johnson, M.B.A., M.P.H.

Bureau of Primary Health Care

Health Resources and Services Administration

Department of Health and Human Services

Bethesda, Maryland

Coryl Jones, Ph.D.

Division of Epidemiology and Prevention Research

National Institute on Drug Abuse

National Institutes of Health

Bethesda, Maryland

Johnnye Mae Jones, Ph.D.

School of Science

Hampton University

Hampton, Virginia

Wanda Jones, Dr.P.H.

Office of Women’s Health

Centers for Disease Control and Prevention

Atlanta, Georgia

Debra R. Judelson, M.D., F.A.C.C., F.A.C.P.

American Medical Women’s Association

Beverly Hills, California

Karol Kaltenbach, Ph.D.

Maternal Addiction Treatment Education 

and Research

Department of Pediatrics

Jefferson Medical College

Philadelphia, Pennsylvania

Sunil D. Kapila, D.D.S., M.S., Ph.D.

Department of Growth and Development

School of Dentistry

University of California, San Francisco

San Francisco, California

Hiroko Karan, Ph.D.

Medgar Evers College

City University of New York

Brooklyn, New York
529

VOLUME 2

Anne Kasper, Ph.D.

Society for the Psychological Study of Social Issues

Bethesda, Maryland

Steve Kaufman, M.D.

Center for Population Research

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Marlene Keeling

Chemically Associated Neurological Disorders

Houston, Texas

Gwendolyn Puryear Keita, Ph.D.

American Psychological Association

Washington, District of Columbia

Joseph Keleghan, M.D., M.P.H.

Early Detection and Community Oncology Program

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Martin J. Kelly, Ph.D.

Department of Physiology and Pharmacology

Oregon Health Sciences University

Portland, Oregon

Thomas H. Kelly, Ph.D.

Department of Behavioral Science

College of Medicine

University of Kentucky

Lexington, Kentucky

Miriam F. Kelty, Ph.D.

National Institute on Aging

National Institutes of Health

Bethesda, Maryland

M. Margaret (Peggy) Kemeny, M.D.

North Shore University Hospital

Manhasset, New York

Teresa R. Kendrix

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Jeanne N. Ketley, Ph.D.

Center for Scientific Review

National Institutes of Health

Bethesda, Maryland

Sooja Kim, Ph.D.

Nutritional and Metabolic Sciences, IRG and 

Endocrinology and Reproductive Sciences

Center for Scientific Review

National Institutes of Health

Bethesda, Maryland

Joan King, Ph.D.

Department of Anatomy and Cellular Biology

Tufts University School of Medicine

Brookline, Massachusetts

Ruth L. Kirschstein, M.D.

Office of the Director

National Institutes of Health

Bethesda, Maryland

Cheryl Kitt, Ph.D.

National Institute of Neurological Disorders 

and Stroke

National Institutes of Health

Bethesda, Maryland

Ann Klassen, Ph.D.

School of Public Health

The Johns Hopkins University

Baltimore, Maryland

Richard D. Klausner, M.D.

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Luella Klein, M.D.

Women’s Health Issues

American College of Obstetricians and Gynecologists

Washington, District of Columbia

Nancy Klein, M.B.A.

Communications and Public Relations

R.O.W. Sciences, Inc.

Rockville, Maryland

Patti J. Klein, Ph.D.

Dow Corning Corporation

Auburn, Michigan

Dushanka Kleinman, D.D.S., M.Sc.D.

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Barbara A. Koenig, Ph.D.

Stanford University Center for Biomedical Ethics

Palo Alto, California
530

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Ann Kolker

Ovarian Cancer National Alliance

Washington, District of Columbia

Laurie Konsella, M.P.A.

Office on Women’s Health

Department of Health and Human Services

Denver, Colorado

Carol Korenbrot, Ph.D.

Institute for Health Policy Studies

University of California, San Francisco

San Francisco, California

Diane Kostyshyn, B.S.

Lilly Center for Women’s Health

Lilly Corporate Center

Indianapolis, Indiana

Jane Kotchen, M.D., M.P.H.

Department of Epidemiology

Medical College of Wisconsin

Milwaukee, Wisconsin

Sarah Kovner

Office of the Secretary

Department of Health and Human Services

Washington, District of Columbia

Deborah A. Kraut, M.I.L.R., M.Ed.

Office of AIDS Research

Office of the Director

National Institutes of Health

Bethesda, Maryland

Fran Kritz

Self Magazine

Silver Spring, Maryland

Fredi Kronenberg, Ph.D.

Center for Complementary and Alternative 

Medicine for Women’s Health

Columbia University College of Physicians 

and Surgeons

New York, New York

Kimberly Kurilla-Gray

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Howard Kurtzman, Ph.D.

Cognitive Science Program

Behavioral Sciences Research Branch

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Leslie J. Kushner, Ph.D.

Urologic Research

Department of Urology

Long Island Jewish Medical Center

New Hyde Park, New York

Sandy Kweder, M.D.

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Pamela S. Laber

Women’s Health

Merck and Company, Inc.

West Point, Pennsylvania

Virginia T. Ladd, R.T.

American Autoimmune Related Diseases Association

Detroit, Michigan

Mary Lamielle

National Center for Environmental Health Strategies

Voorhees, New Jersey

Joseph M. Lane, M.D.

Hospital for Special Surgery

Cornell University Medical College

New York, New York

Patricia Langenberg, Ph.D.

Department of Epidemiology and Preventive Medicine

University of Maryland School of Medicine

Baltimore, Maryland

Judith LaRosa, Ph.D., R.N.

Department of Community Health Sciences

School of Public Health and Tropical Medicine

Tulane University Medical Center

New Orleans, Louisiana

Clarissa LaSalle

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Thomas M. Lasater, Ph.D.

Division of Research

Center for Primary Care and Prevention

Memorial Hospital of Rhode Island/Brown University

Pawtucket, Rhode Island

Deborah Lasky, M.S.

Pharmacia and Upjohn

Herndon, Virginia
531

VOLUME 2

Marianne J. Legato, M.D., F.A.C.P.

Department of Medicine

Columbia University

New York, New York

Wilhelmina Leigh, Ph.D.

Joint Center for Political and Economic Studies

Washington, District of Columbia

Joan M. Leiman, Ph.D.

Commonwealth Fund Commission on Women’s Health

Columbia University

New York, New York

Claude Lenfant, M.D.

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Linda LeResche, Sc.D.

Department of Oral Medicine

University of Washington

Seattle, Washington

Joel Levine, M.D.

Department of Medicine

Science Center

University of Colorado School of Medicine

Denver, Colorado

Anna Levy, M.S.

Planning, Evaluation, and Analysis Branch

Office of Science Policy

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Isabella Liang, Ph.D.

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Marilyn Madry Lightfoote, M.D., Ph.D.

Center for Devices and Radiological Health

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Marian C. Limacher, M.D.

Division of Cardiology

American College of Cardiology

University of Florida College of Medicine

Gainesville, Florida

Lisa Lindahl

Epilepsy Foundation of America

Colchester, Vermont

Brenda Ling, R.Ph.

Pharmacia and Upjohn, Inc.

Bethesda, Maryland

Robyn Lipner, M.A.

Bass and Howes, Inc.

Washington, District of Columbia

Allan Lock, D.V.M.

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Michael D. Lockshin, M.D.

The Barbara Volcker Center for Women 

and Rheumatic Disease

Hospital for Special Surgery

Cornell University Medical College

New York, New York

Claudia Louis, M.B.A.

American Heart Association

Washington, District of Columbia

Judy Luborsky, Ph.D.

Department of Obstetrics and Gynecology

Rush Medical College

Chicago, Illinois

Joanne Luoto, M.D., M.P.H.

Contraceptive and Reproductive Health

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Peter MacPherson

Faulkner and Gray’s Medical Outcomes

New York, New York

Angela Magliozzi

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

Veronica Mallet, M.D.

Women’s Continence Center

Hutzel Hospital Division of Gynecology

Wayne State School of Medicine

Detroit, Michigan
532

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Monique K. Mansoura, Ph.D.

National Human Genome Research Institute

National Institutes of Health

Bethesda, Maryland

Pamela Marino

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Eliot Marshall

Science Magazine

Washington, District of Columbia

Shahla Masood, M.D.

Department of Pathology

University of Florida Medical Center

University of Florida

Jacksonville, Florida

Vickie M. Mays, Ph.D.

Department of Psychology

University of California, Los Angeles

Los Angeles, California

Angela Barron McBride, R.N., Ph.D., F.A.A.N.

Indiana University School of Nursing

Indianapolis, Indiana

Mary E. McCaul, Ph.D.

Comprehensive Women’s Center

Johns Hopkins Hospital

Baltimore, Maryland

Catherine McDermott

National Committee for Quality Health Care

Washington, District of Columbia

Joan A. McGowan, Ph.D.

Musculoskeletal Diseases Branch

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases

National Institutes of Health

Bethesda, Maryland

Eileen McGrath, J.D.

American Medical Women’s Association

Alexandria, Virginia

Donald McNellis, M.D.

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Anne McTiernan, M.D., Ph.D.

WHI Clinical Coordinating Center

Seattle, Washington

Michelle Meadows, B.A.

Closing the Gap

Office of Minority Health

Department of Health and Human Services

Rockville, Maryland

Janet E. Meleney

National Resource Center

Washington, District of Columbia

Nancy K. Mello, Ph.D.

McLean Hospital

Harvard Medical School

Belmont, Massachusetts

Michael Mendelsohn, M.D.

Molecular Cardiology Research Center

NE Medical Center

Boston, Massachusetts

Jack H. Mendelson, M.D.

Alcohol and Drug Abuse Research

McLean Hospital/Harvard Medical School

Belmont, Massachusetts

Laverne G. Mensah, M.D.

Department of Obstetrics/Gynecology

Medical College of Georgia

Augusta, Georgia

Ruth B. Merkatz, R.N., Ph.D., F.A.A.N.

Office of Women’s Health

Pfizer Inc.

New York, New York

Vanessa Merton, J.D.

Pace University School of Law

White Plains, New York

Barbara A. Mikulski, M.S.W. (D-MD)

United States Senate

Washington, District of Columbia

Virginia Miller, Ph.D.

Mayo Clinic

Rochester, Minnesota

Nancy Milliken, M.D.

Center of Excellence in Women’s Health

University of California at San Francisco

San Francisco, California
533

VOLUME2

Sherry Mills, M.D., M.P.H.

Prevention and Control Extramural Branch

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Sukhbir S. Mokha, Ph.D.

Department of Anatomy and Physiology

Meharry Medical College

Nashville, Tennessee

Joseph M. Montella, M.D.

Department of Obstetrics/Gynecology

Jefferson Medical College

Philadelphia, Pennsylvania

Donnica Moore, M.D.

Sapphire Women’s Health Group

Neshamic Station, New Jersey

Constance A. Morella, M.A. (R-MD)

United States House of Representatives Washington, District of Columbia

Marcelle Morrison-Bogorad, Ph.D.

National Institute on Aging

National Institutes of Health

Bethesda, Maryland

Cynthia Casson Morton, Ph.D.

Departments of Obstetrics, Gynecology, 

and Reproductive Biology

Brigham and Women’s Hospital

Boston, Massachusetts

Myla J. Moss, M.S.W., M.A.

Office of Government Relations

American Association of Colleges of 

Osteopathic Medicine

Chevy Chase, Maryland

Ann Mulligan

The DES Cancer Network Washington, District of Columbia

Nathaniel Murdock, M.D.

National Medical Association Washington, District of Columbia

Robert F. Murray, Jr., M.D.

Pediatrics and Medicine

Howard University College of Medicine Washington, District of Columbia

Peter W. Nathanielsz, M.D., Ph.D., Sc.D.

Laboratory for Pregnancy and Newborn Research

Department of Physiology

College of Veterinary Medicine

Cornell University

Ithaca, New York

Eleanor Nealon

Office of Liaison Activities

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

J. Lee Nelson, M.D.

Immunogenetics

Fred Hutchinson Cancer Research Center

The University of Washington

Seattle, Washington

Sasha Nemecek 

Scientific American Magazine

New York, New York

Roberta Ness, M.D., M.P.H.

Department of Epidemiology

Graduate School of Public Health

University of Pittsburgh

Pittsburgh, Pennsylvania

Ann Neville-Jan, Ph.D., O.T.R.

National Center for Medical Rehabilitation 

and Research

National Institutes of Health

Rockville, Maryland

Mary Lynn Newport, M.D.

Department of Orthopaedics

University of Connecticut Health Center

Farmington, Connecticut

Cherie Nichols, M.B.A.

Planning, Evaluation, and Analysis Branch

Office of Science Policy

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Gloria Nichols, Ph.D.

Department of Pharmacy Care Administration

College of Pharmacy

The University of Georgia

Athens, Georgia
534

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Jennifer Niebyl, M.D.

University of Iowa, Hospitals and Clinics

Iowa City, Iowa

Linda C. Niessen, D.M.D., M.P.H.

Department of Public Health Sciences

Baylor College of Dentistry

Dallas, Texas

Ralph M. Nitkin, Ph.D.

Mental Retardation and Developmental 

Disabilities Branch

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Kimberly Nixon

College of Pharmacy and Department of Psychology

Institute of Neuroscience

University of Texas at Austin

Austin, Texas

Cathrine Noe

Arthritis Foundation

Washington, District of Columbia

Judy Norsigian, B.A.

Boston Women’s Health Book Collective

Somerville, Massachusetts

Nancy J. Norton, B.S.

International Foundation for Functional 

Gastrointestinal Disorders

Milwaukee, Wisconsin

Antonia C. Novello, M.D.

Department of Health, Policy, and Management

The Johns Hopkins University

Baltimore, Maryland

Leroy M. Nyberg, M.D., Ph.D.

Division of Kidney, Urologic, and Hematologic Diseases

National Institute of Diabetes and Digestive 

and Kidney Diseases

National Institutes of Health

Bethesda, Maryland

Steven Offenbacher, D.D.S., Ph.D.

Dental Research Center

University of North Carolina

Chapel Hill, North Carolina

Claudia Oglivie, M.S.

United States Army

Fort Detrick, Maryland

Barbara A Osborne, Ph.D.

Department of Veterinary and Animal Sciences

University of Massachusetts

Amherst, Massachusetts

Hibah O. Osman, M.D.

Medical University of South Carolina

Charleston, South Carolina

Ann Ouyang, M.B., B.S.

Section of Gastroenterology and Hepatology

Milton S. Hershey Medical Center

Hershey, Pennsylvania

Pamela Ouyang, M.D.

Johns Hopkins University School of Medicine

Baltimore, Maryland

Kim Painte

USA Today

Arlington, Virginia

Delores L. Parron, Ph.D.

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Estella Parrott, M.D., M.P.H.

Office of Research on Minority and Women’s Health

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

Barbara Parry, M.D.

Department of Psychiatry

University of California, San Diego

La Jolla, California

Nancy L. Parsley, D.P.M.

American Podiatric Medical Association

Bethesda, Maryland

Roland A. Pattillo, M.D.

Department of Obstetrics/Gynecology

Morehouse School of Medicine

Atlanta, Georgia

Mariclaire Payawal

Bristol-Myers Squibb Foundation, Inc.

New York, New York

Christopher K. Payne, M.D.

Division of Urology

Stanford Medical Center

Stanford University

Stanford, California
535

VOLUME2

Deborah Pearlman, Ph.D.

American Cancer Society

Framingham, Massachusetts

Jane Pearson, Ph.D.

Preventive Interventions Research Program

Adult and Geriatric Treatment Branch

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Kathryn Peek, Ph.D.

Medical Education Program in Female 

Clinical Anatomy

University of Texas, Houston

Houston, Texas

Kenneth A. Perkins, Ph.D. Western Psychiatric Institute and Clinic

University of Pittsburgh

Pittsburgh, Pennsylvania Vivian W. Pinn, M.D.

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Frances A. Pitlick, Ph.D.

American Society for Investigative Pathology

Bethesda, Maryland

Dana Points

American Health for Women Magazine

New York, New York

Russell E. Poland, Ph.D.

Department of Psychiatry

Harbor – UCLA Medical Center

University of California, Los Angeles

Torrance, California

Ellyn J. Pollack, M.A., APR

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Jann Primus, Ph.D.

Biology Department

Spelman College

Atlanta, Georgia

Christina Pruett

North Platte, Nebraska

Joan Rachlin, J.D., M.P.H.

Public Responsibility in Medicine and Research

Boston, Massachusetts

Elizabeth Rahdart, Ph.D.

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland

Amelie G. Ramirez, Dr.P.H.

Center for Cancer Control Research

Baylor College of Medicine

Houston, Texas

Bette A. Rank

American Foundation for Urologic Disease, Inc.

Baltimore, Maryland

Mrinalini C. Rao, Ph.D.

Department of Physiology and Biophysics

University of Illinois at Chicago College of Medicine

Chicago, Illinois Vicki Ratner, M.D.

International Cystitis Association

New York, New York

Nancy Reame, M.S.N., Ph.D.

Center for Nursing Research

University of Michigan

Ann Arbor, Michigan

Maryann Redford, D.D.S., M.P.H.

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Joan Y. Reede, M.D., M.P.H., M.S.

Minority Faculty Development Program

Harvard Medical School

Boston, Massachusetts

Amy L. Reisch, M.S.W.

FOCUS on Women’s Health

University of Pennsylvania

Philadelphia, Pennsylvania

Kimber Richter, M.D.

Center for Devices and Radiological Health

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland
536

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Karen Riley

Clinica: World Medical Device and Diagnostic News

Bowie, Maryland

Elena Rios, M.D., M.S.P.H.

Public Health Service Office on Women’s Health

Office of Public Health and Science

Office of the Secretary

Department of Health and Human Services

Washington, District of Columbia

James M. Roberts, M.D.

Magee-Women’s Research Institute

Pittsburgh, Pennsylvania

Joanne Roberts, Ph.D.

SAIC

Frederick, Maryland

Joyce E. Roberts, Ph.D., F.A.A.N.

Women’s Health

University of Illinois at Chicago

Chicago, Illinois

Pamela G. Robey, Ph.D.

Craniofacial and Skeletal Disease Branch

Division of Intramural Research

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Lara Robillard, B.A.

Pharmaceutical Research and Manufacturers of America

Washington, District of Columbia

David Robinson, Ph.D.

Vascular Research Program

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Laurie Robinson, M.T.S.

Office on Women’s Health

U.S. Public Health Service

Department of Health and Human Services

Boston, Massachusetts

Roxanne A. Rodney, M.D.

Division of Cardiology

Columbia-Presbyterian Medical Center

Columbia University

New York, New York

Helen Rodriguez-Trias, M.D.

Public Health Institute

The Pacific Institute for Women’s Health

Los Angeles, California

Marianne Rollings, B.S.

Virginia Department of Medical Assistance Services

Richmond, Virginia

Adele Roman, M.S.N., R.N.

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland

Martha Romans

Jacobs Institute of Women’s Health

Washington, District of Columbia

Annette Ronnbla, M.S.

Washington, District of Columbia

John Rose, M.D.

Department of Neurology

University of Utah

Salt Lake City, Utah

Joan K. Rosenbach, Ph.D.

JKR Associates

Chevy Chase, Maryland

Barbara Ross-Lee, D.O.

College of Osteopathic Medicine

Ohio University

Athens, Ohio

Karen H. Rothenberg, J.D., M.P.A.

University of Maryland School of Law

Baltimore, Maryland

Deborah Rubin, M.D.

Division of Gastroenterology

Washington University School of Medicine

St. Louis, Missouri

Maryann T. Ruda, Ph.D.

Cellular and Molecular Mechanisms

Pain and Neurosensory Mechanisms Branch

Division of Intramural Research

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Joyce Rudick

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland
537

VOLUME 2

John Rugh, Ph.D.

Dental School, Orthodontics

University of Texas Health Sciences Center

San Antonio, Texas

Elizabeth Ruksznis

American Psychological Society

Washington, District of Columbia

Susan Runner, D.D.S., M.A.

Dental Devices Branch

Center for Devices and Radiological Health

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Rosalie Sagraves, Pharm.D., F.C.C.P.

College of Pharmacy

University of Illinois at Chicago

Chicago, Illinois

Sharon Samber

National Clearinghouse for Alcohol and 

Drug Information

Rockville, Maryland

Charlotte (Barney) Sanborn, Ph.D.

Center for Research on Women’s Health

Texas Woman’s University

Denton, Texas

Gloria Sarto, M.D., Ph.D.

Obstetrics and Gynecology

University of New Mexico School of Medicine

Albuquerque, New Mexico

Anne Sassaman, Ph.D.

Division of Extramural Research and Training

National Institute of Environmental Health Sciences

National Institutes of Health

Research Triangle Park, North Carolina

Gerald Schatten, Ph.D.

Center for Women’s Health

Oregon Health Sciences University

Beaverton, Oregon

Eleanor Schron, M.S., R.N., F.A.A.N.

National Heart, Lung, and Blood Institute

National Institutes of Health

Bethesda, Maryland

Joan P. Schwartz, Ph.D.

National Institute of Neurological Disorders 

and Stroke

National Institutes of Health

Bethesda, Maryland

Julia Scott, R.N.

National Black Women’s Health Project

Washington, District of Columbia

Susan Scott, M.D.

Department of Pediatrics, Ambulatory Care

UNM Health Sciences Center

University of New Mexico School of Medicine

Albuquerque, New Mexico

Veronica J. Scott, M.D., M.P.H.

Center on Aging

Meharry Medical College

Nashville, Tennessee

Barbara Seaman

New York, New York

Diane K. Seay

Girls and Mentors Manifesting Achievement Project

National Association for the Advancement of 

Women in Science

University of New Mexico

Albuquerque, New Mexico

Wesley Segawa

Emory University School of Nursing

Hilo, Hawaii

Susanna Serrate-Sztein, Ph.D.

Arthritis Program

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases

National Institutes of Health

Bethesda, Maryland

Emily Shactor, Ph.D.

Center for Biologics, Evaluation, and Research

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Ellen R. Shaffer, M.P.H.

Special Projects

Agency for Health Care Policy and Research

Rockville, Maryland

Sally Shaywitz, M.D.

Yale University School of Medicine

Woodbridge, Connecticut

M. Katherine Shear, M.D.

Western Psychiatric Institute and Clinic

University of Pittsburgh

Pittsburgh, Pennsylvania
538

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Amy Shenker, M.P.P.

Porter Novelli

Washington, District of Columbia

Audrey Sheppard

Office of Women’s Health

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Amanda Sherman

DES Action, USA

Siasconset, Massachusetts

Sherry Sherman, Ph.D.

Clinical Endocrinology and Osteoporosis Research

Geriatrics Program

National Institute on Aging

National Institutes of Health

Bethesda, Maryland

Cynthia Shewan, Ph.D.

Research and Scientific Affairs

American Academy of Orthopaedic Surgeons

Rosemont, Illinois

Eleanor G. Shore, M.D., M.P.H.

Harvard Medical School

Boston, Massachusetts

Sally A. Shumaker, Ph.D.

Department of Public Health Service

Social Sciences and Health

Wake Forest University Medical Center

Bowman Gray School of Medicine

Winston-Salem, North Carolina

Steven G. Silverberg, M.D.

Department of Anatomic Pathology

The University of Maryland Medical System

Baltimore, Maryland

Susan F. Silverton, M.D., Ph.D.

School of Dental Medicine

University of Pennsylvania

Philadelphia, Pennsylvania

Louise M. Slaughter, M.S. (D-NY)

United States House of Representatives

Washington, District of Columbia

Harold C. Slavkin, D.D.S.

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Lois Slavkin

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Tracey Small Nilson, M.D.

University of Connecticut

Hartford, Connecticut

Wendy B. Smith, Ph.D.

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

Rockville, Maryland

Lynn Snyder-Mackler, Sc.D., P.T.

Section on Research

University of Delaware

American Physical Therapy Association

Newark, Delaware

Linda Sommerfield

Department of Surgery

Section of Otolaryngology

Yale University School of Medicine

New Haven, Connecticut

Christine G. Spain, M.A.

President’s Council on Physical Fitness and Sports

Office of Public Health and Science

Office of the Secretary

Department of Health and Human Services

Washington, District of Columbia

Rebecca Spieler

The Blue Sheet

Chevy Chase, Maryland

Amanda Lee Spitler, J.D.

American College of Rheumatology

Washington, District of Columbia

Shobha Sriharan, Ph.D.

Department of Agriculture

Sponsored Programs (NIH)

Virginia State University

Petersburg, Virginia

Sharilyn Stanley, M.D.

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Bethesda, Maryland
539

VOLUME2

Carolyn Stern, M.D.

Family Practice Center

Park Ridge, Illinois

Donna E. Stewart, M.D., D.Psych.

The Toronto Hospital

University of Toronto

Toronto, Ontario, Canada

Louis Stokes, J.D. (D-OH)

United States House of Representatives Washington, District of Columbia

Ora Lee Strickland, Ph.D.

Nell Hodgson Woodruff School of Nursing

Emory University

Atlanta, Georgia

Deborah Studen-Pavlovich, D.M.D.

Division of Women and Minority Affairs

School of Dental Medicine

University of Pittsburgh

Pittsburgh, Pennsylvania

Anne E. Sumner, M.D.

Institute of Women’s Health, Allegheny

Philadelphia, Pennsylvania

Linda Sussman, Ph.D.

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Dace Svikis, Ph.D.

Johns Hopkins University School of Medicine

Baltimore, Maryland

Ana Szarfman, M.D., Ph.D.

Center for Drug Evaluation and Research

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Ramona Tascoe, M.D.

Council on the Concerns of Women Physicians

National Medical Association

Oakland, California

Anne S. Tatem, M.P.A.

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases

National Institutes of Health

Rockville, Maryland

Sheila E. Taube, Ph.D.

Cancer Diagnosis Program

Division of Cancer Treatment

National Cancer Institute

National Institutes of Health

Rockville, Maryland

Anne L. Taylor, M.D. Women’s Health Programs

Department of Medicine

University Hospital of Cleveland

Case Western Reserve University

Cleveland, Ohio

Diana Taylor, Ph.D., R.N.

Department of Family Health Care Nursing

University of California, San Francisco

San Francisco, California

Nancy Teed, M.A.

Houston Associates, Inc.

Silver Spring, Maryland

Linda A. Teplin, Ph.D.

Northwestern University Medical School

Chicago, Illinois

Pushpa V. Thadani, Ph.D.

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland

Linda A. Thomas, Ph.D.

Inherited Diseases and Disorders Program

Division of Extramural Research

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Sarah Moody Thomas, Ph.D.

Stanley Scott Cancer Center

Louisiana State University Medical Center

New Orleans, Louisiana

Diane S. Thompson, M.D. Western Psychiatric Institute and Clinic

University of Pittsburgh

Pittsburgh, Pennsylvania

Winston E. Thompson, Ph.D.

Department of Obstetrics and Gynecology

Morehouse School of Medicine

Atlanta, Georgia
540

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Brenda B. Toner, Ph.D.

Women’s Mental Health Research Program

Clark Institute of Psychiatry

University of Toronto

Toronto, Ontario, Canada

Laura Lowe Tosi, M.D.

Children’s National Medical Center

George Washington School of Medicine

Washington, District of Columbia

Edward L. Trimble, M.D., M.P.H.

Surgery Section

Cancer Therapy Evaluation Program

Division of Cancer Treatment, Diagnosis, and Centers

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Theresa Tuigo, M.P.H., M.B.A.

Food and Drug Administration

Department of Health and Human Services

Rockville, Maryland

Lorraine Tulman, R.N., D.N.Sc.

Agency for Health Care Policy and Research

Rockville, Maryland

Patricia Turner

National Institute of Neurological Disorders 

and Stroke

National Institutes of Health

Bethesda, Maryland

Sandra Million Underwood, R.N., Ph.D.

University of Wisconsin – Milwaukee

Milwaukee, Wisconsin

Wulf H. Utian, Ph.D.

Department of Obstetrics and Gynecology

Department of Reproductive Biology

Case Western Reserve University

Cleveland, Ohio

Henrikas Vaitkevicius, B.S.

John Dingle Virginia Medical Center

Wayne State University

Detroit, Michigan

Ann VanSant, P.T.

Section on Research

Physical Therapy Department

Temple University

American Physical Therapy Association

Philadelphia, Pennsylvania

Claudette Varricchio, D.S.N.

Division of Cancer Prevention and Control

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Donald R. Vereen, M.D., M.P.H.

Office of the Director

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland

Ebrahim Versi, M.D., Ph.D., M.R.C.O.G., B.S.

Department of Obstetrics/Gynecology

Brigham and Women’s Hospital

Boston, Massachusetts

Lydia Villa-Komaroff, Ph.D.

Northwestern University

Evanston, Illinois

Donna L. Vogel, M.D., Ph.D.

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Rhonda Voskuhl, M.D.

Department of Neurology

University of California

Los Angeles, California

Meredith Wadman

Nature

Washington, District of Columbia

Charlene Waldman

The Paget Foundation for Paget’s Disease of Bone 

and Related Disorders

New York, New York

Jacqueline Wallen, Ph.D.

Department of Family Studies

College of Health and Human Performance

University of Maryland

College Park, Maryland

Denise C. Webster, R.N., Ph.D.

School of Nursing

University of Colorado Health Sciences Center

Denver, Colorado
541

VOLUME 2

Anita Corman Weinblatt, Ph.D.

Immunological Sciences Study Section

Initial Review Group

Center for Scientific Review

National Institutes of Health

Bethesda, Maryland

Carl Weiner, M.D.

OB/GYN Reproductive Services

University of Maryland

Baltimore School of Medicine

Baltimore, Maryland

Constance Weinstein, Ph.D.

Edmonds, Washington

Jane Weintraub, D.D.S., M.P.H.

Department of Dental Public Health and Hygiene

School of Dentistry

University of California, San Francisco

San Francisco, California

Gerson Weiss, M.D.

Department of Obstetrics/Gynecology

UMDNJ – New Jersey Medical School

Newark, New Jersey

Kim Weiss

National Association of Professionals in 

Women’s Health

Chicago, Illinois

Sheila R. Weiss, Ph.D.

University of Maryland at Baltimore

Baltimore, Maryland

Sandra Welner, M.D.

Primary Care Gynecology for Women with Disabilities

Silver Spring, Maryland

Nanette K. Wenger, M.D.

Emory University School of Medicine

Atlanta, Georgia

Cora Lee Wetherington, Ph.D.

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland

Cornelia Weyand, M.D., Ph.D.

Department of Medicine

Division of Rheumatology

Mayo Clinic and Foundation

Rochester, Minnesota

Judith M. Whalen, M.P.A.

National Institute of Child Health and 

Human Development

National Institutes of Health

Bethesda, Maryland

Caroline C. Whitacre, Ph.D.

Department of Microbiology/Immunology

Ohio State University

Columbus, Ohio

Alex White, D.D.S., Dr.P.H.

Center for Health Research

Kaiser Permanente

Portland, Oregon

Catherine A. White, Ph.D.

College of Pharmacy

The University of Georgia

Athens, Georgia

Kristene E. Whitmore, M.D.

Allegheny University

Philadelphia, Pennsylvania

Judy Williams, Ph.D.

School of Science and Technology

Southeastern Oklahoma State University

Durant, Oklahoma

Sharon Wilsnack, Ph.D.

Department of Neuroscience

University of North Dakota School of Medicine 

and Health Sciences

Grand Forks, North Dakota

Joanne A.P. Wilson, M.D., F.A.C.P.

Division of Gastroenterology

Duke University Medical Center

Durham, North Carolina

Marlene A. Wilson, Ph.D.

Department of Pharmacology

University of South Carolina School of Medicine

Columbia, South Carolina

Deborah M. Winn, Ph.D.

Oral Health Promotion

Risk Factors and Molecular Epidemiology Branch

Division of Intramural Research

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland
542

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Richard Winneker, Ph.D.

Women’s Health Research Institute

Wyeth-Ayerst Research

Radner, Pennsylvania

Mollie Winston, D.D.S.

Atlanta, Georgia

Susan Wise, B.S.

Office of Planning, Evaluation, and Communication

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Whitney Witt, M.P.H.

Office of Science and Epidemiology

HIV/AIDS Bureau

Health Resources and Services Administration

Department of Health and Human Services

Rockville, Maryland

Jacqueline Wolf, M.D.

Division of Gastroenterology

Brigham and Women’s Hospital

Boston, Massachusetts

Susan F. Wood, Ph.D.

Public Health Service Office on Women’s Health

Office of Public Health and Science

Office of the Secretary

Department of Health and Human Services

Washington, District of Columbia

Nancy Fugate Woods, Ph.D., R.N.

Center for Women’s Health Research

University of Washington, Seattle

Seattle, Washington

Raymond J. Woosley, M.D., Ph.D.

Department of Pharmacology

Georgetown University Medical Center

Washington, District of Columbia

Darlene Yee, Ed.D., C.H.E.S.

College of Health and Human Services

San Francisco State University

San Francisco, California

Ruth York, R.N., Ph.D.

Association of Women’s Health, Obstetrics and 

Neonatal Nurses

Washington, District of Columbia

Roxanne Ward Zaghab, M.S.W.

Department of Epidemiology and Preventive Medicine

University of Maryland School of Medicine

Baltimore, Maryland

Cheryl Zimmerman, Ph.D.

Department of Pharmaceutics

College of Pharmacy

University of Minnesota

Minneapolis, Minnesota
543

VOLUME 2

A

abortion, spontaneous 28, 169, 171, 174, 238, 443

abuse, long-term effects 26, 120

access to treatment 60, 123

adhesive capsulitis (see frozen shoulder)

adolescents

smoking 24, 62, 293

STDs 67, 171, 248, 318–19

Adverse Event Reporting System (AERS) 235

advertising 24, 33, 62, 451

Agency for Health Care Policy and Research 178, 516,

537, 540

agoraphobia 26, 112, 116

AIDS

and mental health 118, 121

pediatric 25

and women 24, 102, 104, 106, 139, 172, 207,

213, 219, 225, 233, 238, 248, 250, 254, 

288, 302, 321, 408, 410, 429

AIDS Clinical Trial Group 076 102–03

alcohol

abuse 24, 443

and aggression 29–30

associated liver disease 24

metabolism of 28, 31

symptoms of dependency 24

treatment programs 24, 27

alcohol and other drug (AOD) use, maternal 32, 396

alcohol dehydrogenase (ADH), gastric 28

alcoholic cardiomyopathy 24

Allegheny University of the Health Sciences 6

Alliance on Aging 275

alternative medicine 147, 334, 380

Alzheimer’s disease 133, 164, 313, 322, 373

American Association of University Women (AAUW)

190

American Cancer Society 61, 63, 375, 414, 519, 535

American Heart Association 74, 79, 251, 302, 309,

317–18, 336, 358, 531

American Psychological Association 34, 37, 41, 345,

355, 371, 408, 435, 482, 529

American Urological Association 178

androgens 99, 126, 171–72

anemia 13, 68, 177, 203, 393, 453

angioplasty, rates of 203

animal models 31, 33, 78, 104, 107, 129, 208, 443

anorexia nervosa 117, 369

anovulation 69

anterior cruciate ligament 55

Antihypertension and Lipid-Lowering Treatments to

Prevent Heart Attack Trail 273

antisocial personality disorder 28

anxiety disorder 26, 29–30, 32–33, 112, 116–17, 

120–21, 125

Arizona State University 190

arthritis

osteoarthritis 43, 47–48, 389, 420, 443–44,

459–60

rheumatoid 43, 50–51, 93, 96, 98, 208, 258, 

319, 420, 435, 447, 453, 459–60

ASSIST study 60

Association for Women in Science 190, 369–70

Association of American Medical Colleges 315

asthma

in children 12

atherosclerosis 12, 73, 78, 93, 318, 336

attention deficit hyperactivity disorder (ADHD) 123

autoimmune diseases 41, 93–99, 141, 225, 259, 310,

314, 320–22, 352, 388, 396, 413, 437–38, 514

autoimmunity 96, 98, 260, 320–21, 437–38

B

battering (see domestic violence)

Bayh-Dole Act of 1982 232

Behavior Risk Factor Surveillance Survey 56

behavioral research iii, xiii, 1, 4, 12, 65–66, 71,

117–18, 167, 215, 307–08, 312–13, 319, 

343–44, 411

INDEX
544

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

bipolar disorder, rapid-cycling (see also depression)

111, 113, 123

birth control 17, 63, 66, 69, 95–96, 106–07, 113,

154, 209, 232, 261, 313

birthweight, low 139, 203, 252, 346–47, 349, 372,

393–94, 410, 417, 450, 457

blood pressure (see hypertension) 116, 174–75, 

180, 201, 242, 292, 339, 366, 394

Bogalusa Heart Study 336

bone demineralization, premature 368

bone density 28, 45–46, 50–51, 53, 142, 200, 

249, 442

bone mass, black/white differences 48, 50–51, 

53–54, 57, 86, 200, 312, 317, 332, 368–69, 

419, 441–42, 464

bone remodeling 52

bowel disorders 81, 88, 333, 469

brain disorders 24, 125–26, 128, 435

brain molecular anatomy project 12

BRCA1 gene 38, 64, 66, 256, 258–59, 261, 406

BRCA2 gene 64, 66, 258, 406

breast cancer (see cancer)

breastfeeding, and drug use 157, 161

breast implants 342–43, 375, 396, 435

bulimia 24, 34, 112, 117–18, 120, 124, 346

Burkitt’s lymphoma 60

burning mouth 136, 138, 141, 393

C

cancer

bladder 453–54

breast 17, 26, 29, 38, 41–43, 51, 53–54, 59–60,

63–67, 72–74, 77, 81–82, 109, 164, 199,

213, 225, 233, 245, 249–51, 253, 258–59,

263, 271, 281–83, 300, 302, 313, 317, 322,

339, 355, 358, 363, 375, 380, 386–87, 390,

392, 398, 401, 405–06, 414, 424–25, 430,

468, 470, 479, 487, 501–02, 511, 521

cervical 67–68, 70, 72, 82–83, 102, 200, 248,

253, 280, 348, 363, 366, 378–79, 398, 410,

414, 445, 504

colon 12, 60, 65–66, 69, 81–83, 87, 90, 251,

259, 333, 468

colorectal 59, 65, 81–83, 87, 90–91, 251, 

333, 379, 468

endometrial 60, 69, 81–82, 87, 217, 398

lung 59–63, 70, 77, 245–46, 267, 283, 300,

424–25, 427

ovarian 63–64, 66–67, 72, 77, 213, 245, 248,

387, 398, 408, 411, 414, 436–37, 445, 530

and smoking 60–61, 67, 70, 135, 283, 292, 

394, 424–25

uterine cancer 59, 68–69, 200

Cancer Genetic Studies Consortium 259

Cancer Genome Anatomy Project 282

candidiasis, oral 138, 142

cardiovascular disease xiv, 9, 12, 14, 38, 41, 55, 60,

64, 73–79, 142, 144, 167, 174, 179, 241, 249,

267, 274, 276–77, 317, 328, 336, 339, 347, 358,

361, 391, 410, 428, 444–45, 447–49, 464–65,

470, 474, 484, 526

career issues

in gastroenterology 81

in oral research and oral health 140, 142–43

for women scientist 7, 10, 13, 89–90, 187–91,

193–95, 226–27, 307–08, 323–24, 330, 333,

351–52, 369–70, 377, 391, 411, 463, 466

care givers/caregiving 26, 40, 56, 112, 122, 136, 247,

259, 426, 434

carpal tunnel syndrome 48, 54, 429, 446

Center for Bioenvironmental Research (CBR) 217, 

222, 491, 493, 495

Centers for Disease Control and Prevention (CDC) 

34, 37, 46, 56, 58, 72, 101, 105, 232, 234, 250,

367, 378, 418, 478, 482, 492–93, 504, 506–07,

511, 519, 528

cerebrovascular disease 24, 44, 198

cervical dysplasia 200

cesarean delivery 102, 169, 357

chancroid 319

Children’s Depression Inventory 114

chlamydia 102–03, 105–06, 109, 248, 318–19, 

324, 378

chronic fatigue syndrome (CFS) 109, 224–25, 

335, 497

chronopharmacology 150, 155, 160

churches – and clinical trials 221, 326

clinical studies

ethical and liability considerations 4, 207

inclusion of women 1, 3, 18, 206–07, 210, 

216, 267

cirrhosis 24, 33, 84–86, 88–89, 333, 415–16
545

VOLUME 2

Clinical Laboratory Improvement Act (CLIA) 105

cocaine, self-administration of 30

cognitive impairment 118, 128, 135–36

colitis, ulcerative 86

Colles’ fracture 51, 446

COMMIT study 60

Commonwealth Fund, The 35, 38, 41, 384, 477, 

480, 520

community leaders – and clinical trials 218–19

comorbidity 25, 27, 30, 112, 114, 117, 121, 475

conduct disorder 29

Congressional Black Caucus 253

Congressional Caucus for Women’s Issues 2, 9, 248

consensus statement 240

contraception 168–71, 233, 249, 319–20, 350,

353–54, 440, 475

coronary artery bypass surgery, rates of 203

coronary artery disease 12, 24, 73, 336

Coronary Drug Project 272

Council of Graduate Medical Education 189

Council of Social Work Education 345

counseling, long-term 29

crack cocaine 24–25, 34

crime victims 29, 31

criminal justice system 123

Crohn’s disease 86, 90–91

cross-disciplinary research 27, 121

cystic fibrosis (CF) 257–58, 271

D

dehydroepiandrosterone (DHEA) 171–72, 403

dental research 466

Denver General Hospital 202

Department of Defense, U.S. 63, 386, 425

Department of Housing and Urban Development, U.S.

217

depression

and drug abuse 24, 26, 121

and heart attack 116

late life 51, 119

major 29, 111, 113–14, 117, 418

and pregnancy 114, 116, 202

unipolar 111, 113–14

DES (diethylstilbestrol) 4, 69, 249–51, 335, 353, 

356, 385–86, 408, 445, 461–62, 497, 508–09,

520, 533, 538 

diabetes

cardiovascular inplications of 76–78

gestational 76, 378

Type 1 (insulin dependent) 76–77, 92, 99, 175,

177, 260, 437

Type 2 (noninsulin dependent) 77, 86, 138,

173–75, 180, 182, 361

Diagnostic and Statistical Manual, Fourth Edition

(DSM-IV) 24

dialysis 173–74, 177, 179, 183

digestive diseases 41, 81, 86, 89, 468

dimorphism, sexual 11, 96, 127, 130, 314

disabilities 1, 6–7, 23, 27, 36, 44, 46, 55–56, 77, 

119, 123–24, 132, 169, 190, 195, 199, 203, 

364, 366–67, 373–74, 390, 401–03, 426, 438

diversity (see also minority groups)

14, 17, 27, 37, 39, 77, 121, 214, 216, 233, 

253, 300, 363, 424, 442, 468, 474, 476

domestic violence 116, 122, 140, 209, 225, 364, 

378, 400, 417–18, 429

drug abuse

treatment, outpatient 30

Drug Abuse Treatment Outcome Study (DATOS) 30

drug access, gender effects on 241

drug compliance, gender effects on 241

drug interactions 154, 158–59, 162, 236–37, 239

Dual Energy X-ray Absorptiometry (DEXA) 441–42

dyslipidemia 13, 336

dysthymia 111, 114

E

early menopause 24, 64, 443, 449

East Indian women (see minority groups)

eating disorders (see also anorexia and bulimia)

24–26, 31, 50, 55, 112, 117–18, 121–22, 124,

129, 136, 170, 209, 300, 346, 368, 411, 418,

464–65, 474–75

and drug abuse 25

elderly women 39, 52, 58, 128, 359–60, 393

electroconvulsive therapy (ECT) 114

embryo research 268–70, 315–16

emerging infections 109–10, 324
546

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Emory School of Nursing 219

end-of-life care 426

endometriosis 168, 170, 172, 313, 365, 390, 475

environmental toxicants/contaminants/chemicals

and pregnancy 388–90, 372

tobacco smoke 281

Epidemiologic Catchment Area (ECA) study 113, 117

epilepsy 125–27, 129, 131–32, 157, 440, 465

Epstein-Barr virus 60

estrogen replacement therapy (ERT) 28–29, 63, 69,

96, 127–28, 160, 317, 339, 369, 444, 464

estrogens, environmental 96

ethnicity (see also minority groups)

v, 20, 31–32, 35–36, 39, 50, 61, 79, 84, 112, 

119, 187, 192, 199–200, 203, 214, 219–21, 

236, 280, 329, 344–45, 368, 373, 380, 398, 

447, 460, 499–500

exercise

effect on bone and muscle health 50–51, 57

F

Federal Technology Transfer Act of 1986 232

female athlete triad 46, 55, 58

fertility 28, 33, 63, 67, 71, 97, 168, 170, 172, 174,

179, 319, 365, 386, 389, 392, 431, 440, 443–44

fetal environment 75, 78

fetal research 268–69

fibromyalgia 50, 138, 342, 376, 421

fluoride 50, 52, 317

Food and Drug Administration (FDA) 9, 11, 62, 

64, 68, 70, 148, 156–57, 205, 207–08, 231–35,

246–47, 250, 266, 276–77, 342, 354, 375, 457

Food and Drug Law Institute 9

foot disorders 448–49

foot pain 448–49, 456–57

forefoot pain 456

Forsyth County Cancer Screening Project 379

Framingham Heart Study 272

frozen shoulder (adhesive capsulitis) 53, 422–23, 467

G

gallbladder disease 87, 337

GenBank 13

gender differences in

arthritis and disability 43, 45, 48–49, 209, 421,

449–50, 457, 463

brain development, organization, and functioning

121–23, 126, 130

clinical study design 126, 205, 208–09, 216

clinical study participation 5, 15, 354

clinical trials 9, 18, 33, 98, 108, 205–06, 216,

266, 272, 306, 354, 381

cognitive and/or personality variables 25, 112

depression rates 114, 209

drug delivery 457

drug responses 148, 208

effects of drug abuse and addiction 25

longitudinal studies 33

mental disorders 111, 120, 122, 124

postoperative analgesia 71, 138

psychopharmacology 120

restorative procedures 43

sensory perception and pain 126

smoking 61–62, 209, 239, 283, 424, 451

taste perception 138

treatment 15, 18–19, 33, 55, 111–13, 129–30,

140, 160, 267

gender-based biology 267, 315, 427

genecity 267

General Accounting Office (GAO) 2–3, 8–9, 245, 248

genetic testing, prenatal 420

genetics

as basis of alcoholism 17, 28, 263

imprinting 126, 256, 269

risk, of AOD abuse 32

screening 38, 60, 94, 169, 271

testing 18–19, 70, 168, 171, 225, 249, 257,

263–64, 271, 420, 470, 475

genital prolapse 176, 179, 181, 431

genomics 17, 96, 261, 514

glass ceiling 286

Global Burden of Disease study 111

gonadal hormones 26, 120, 122, 130–31

gonorrhea 105, 107, 248, 318–19, 378

Guidelines on Inclusion of Women and Minorities in

Clinical Studies 215

gynecologic surgery, complications of 310
547

VOLUME 2

H

hair combing interactions 344–45

Harvard Medical School 189, 330, 382–85, 462

Harvard School of Public Health 220, 384

Health Care Financing Administration (HCFA) 240

health education 7, 147, 210, 223, 334, 358, 380,

423, 442, 465

Health Interview Survey, 1994 65

Health Resources and Services Administration 

(HRSA) 5, 429–30

Healthy Heart Handbook for Women 275

Healthy People 2000 371, 397

Heart and Estrogen-Progestin Replacement Study 

(HERS) 313

heart attack 73–74, 77, 111, 116, 155, 203, 246, 

251, 253, 273–74, 276–77, 317, 328, 358, 453

Helicobacter pylori (H. pylori) 60, 109, 333, 469

hepatitis

autoimmune 84–85, 89, 415–16

B 103, 105, 415–16

C 12, 105, 109

herpes

human herpes virus 8 (HHV8) 60

Hispanic women (see minority groups)

hormones

exogenous 106, 145, 150, 159, 162, 171, 237

and neurotransmitters 94, 125, 158

sex hormones on adult cognition 126

Human Embryo Research Panel of 1994, NIH 

269–70

Human Genome Project 18, 265, 269

human immunodeficiency virus (HIV) (see also AIDS)

12, 25, 27, 30, 67–68, 70, 74, 101–10, 118,

120–21, 124, 136, 138–39, 142, 144, 149, 

159, 172, 219, 221, 225, 231, 233, 238, 241,

248–49, 279, 288, 318–19, 321, 324–25, 348,

350, 353, 378, 398–99, 410, 417, 429–30, 

434, 444, 475, 542

human Papilloma virus (HPV) 67–68, 70, 102,

104–06, 200, 248, 280

Hunt Valley Report, 1991 3, 6–7, 103, 112, 308

hypercholesterolemia – in minority patients 203

hyperemesis gravidarum 87

hyperparathyroidism 54, 467–68

hypertension 10, 12–13, 44, 76, 157, 174, 178, 

180, 183, 200–01, 203, 208, 213, 220, 273, 

275, 328, 336, 347, 373, 394, 415, 418, 453

Hypertension Detention and Followup Program 272

hypothalamic pituitary adrenal (HPA) 127–28, 314

hysterectomy 68–69, 206, 310, 445

I

immigrants 123, 199, 286

immune function 3, 94, 96–97, 99, 314, 444

immunity

hormonal effects on 97

innate 98–99

mucosal 94, 139

incarcerated women 105

incontinence

fecal 430, 432

overflow 176

stress 176, 201

urge 176

urinary 108, 174, 176, 178, 181–83, 201, 

391, 428, 432, 453–54

incrementalism 265–66

infectious diseases 3, 12, 101, 103, 105–07, 

109–10, 168, 171, 324, 361, 410–11

infertility 17, 66, 101, 104, 107, 168–70, 172, 

248, 269, 300, 313, 315, 331, 365, 386, 

388, 390, 410, 431, 475

inflammatory bowel disease 82, 86, 93

informed consent 207, 233, 263–64, 271, 310, 

350, 433

injuries, sports-related 46, 55, 58, 332, 391, 

428, 467

Institutional Review Board shopping 233

interstitial cystitis (IC) 2, 174, 177, 179, 181–83,

453–56

ion channels 150, 154, 158, 160

irritable bowel syndrome 81, 83, 87–88, 90–91, 

333, 337, 448, 469

J

joint disease, end-stage 48
548

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

K

Kaiser Foundation Research Institute 220

Kegel exercises 176

Kennedy-Kassebaum bill 268

Komen Foundation 250

L

leadership, in scientific careers 5, 140, 187–88,

190–91, 194, 385

lesbians (see also sexual orientation)

6, 23, 27, 123, 169, 199, 202, 221, 325, 

398–400

life expectancy 173, 213, 274, 400

Lipid Research Clinics Coronary Primary Prevention

Trial 273

lithium 114, 119

liver diseases, autoimmune 84

long QT syndrome 13

longitudinal studies 114, 162

low birthweight 139, 203, 253, 347–48, 350, 373,

396–97, 410, 417, 453, 461

lupus nephritis 175, 178, 180, 182

Lynch II syndrome 65, 69, 175

M

malaria 109

mammography 63–65, 249, 280

managed care – role in women’s health research 69,

100, 206, 247, 266

manic depression (see also bipolar disorder)

112, 126

mastectomy 64, 263, 405–06

medical education 192, 294–96, 315, 383–84, 411

membrane transporters 150, 154, 160–61

Memory Study, Women’s Health Initiative 313

menopause

and mental disorders 122

and mood 122

menstrual cycle

and AOD use 27–28, 31, 149–150, 206, 443

effect on injury rates 55

mental disorders, prevention 41, 123

mentoring, in scientific careers 36, 89, 142, 189, 

191, 194–95, 311, 323, 333, 351–52, 370, 

383, 466, 469

metabolic bone disease 52, 86, 89, 145

microbicides 104, 106, 108, 139, 168, 170, 409–10

microchimerism 94, 96–97

migraine headache 44, 128, 138

military women 362, 387

minority groups

African American 15, 153, 248, 253–54, 253,

263, 283, 288, 316, 321, 326, 328, 338, 

345–46, 348, 368, 373, 379, 382, 414, 

452–53, 501

Alaskan Native 199, 213–14

American Indian/Native American 61–62, 72, 

77, 88, 175, 192, 199–200, 213–14, 217–18,

358–59, 361, 378, 382, 390, 394–95, 397,

502–03, 505, 519

Asian 51, 62, 64–65, 68, 72, 74, 119, 151, 165,

192, 199, 201, 213–15, 218, 288, 347, 356,

373, 392, 395, 404–05, 501, 511

East Indian 419

Hispanic 12, 24, 47, 62–63, 72, 74, 114, 175,

192, 199–203, 213–14, 217–18, 222, 288,

309, 331, 347, 355, 358–59, 363, 377, 384,

390, 394–95, 397, 429, 452, 501, 506

Pacific Islander 65, 72, 74, 199, 213–14, 217,

288, 392

mobility 55, 359, 366, 433, 467

mortality rates, infant 201

multidisciplinary research

careers 226

conferences 36

coordinating groups 225

core centers 225

importance of 32, 223–24, 226

reviewers with expertise 228

teams 223, 225

training 36, 223, 226

awards 227

programs 226

Multiple Risk Factor Intervention Trial (MRFIT) 273

multiple chemical sensitivities (MCS) 377, 438–39

multiple sclerosis (MS) 97–99, 125–26, 260, 314,

320, 322, 432, 437

myasthenia gravis 126, 314

myocardial infarction 116, 128, 139, 209, 439
549

VOLUME 2

N

National Academy of Sciences 271, 438

National Action Plan on Breast Cancer 262

National Black Women’s Health Network 1

National Black Women’s Health Project 302

National Cancer Genetics Network 259

National Cancer Institute (NCI) 59, 61, 63, 65, 68,

70, 248, 259, 267, 277, 281, 284, 363, 379, 

385, 414, 425, 461–62

National Center for Health Statistics 44–47, 74–77,

214, 317, 329, 432

National Comorbidity Survey 24, 112

National Health and Nutrition Examination Survey III

(NHANES III) 46, 48, 84, 135, 137, 312

National Health Interview Survey 43–44, 56, 449

National Heart, Lung, and Blood Institute (NHLBI) 

44, 76, 272, 274

National Household Survey on Drug Abuse 24

National Institute of Allergy and Infectious Diseases

(NIAID) 101, 322–23

National Institute of Child Health and Human 

Development (NICHD) 232, 411

National Institute of Dental Research (NIDR) 

136, 138, 323, 466

National Institute of Nursing Research (NINR) 

189, 286, 461

National Institute on Alcohol Abuse and Alcoholism

(NIAAA) 23, 32

National Institute on Drug Abuse (NIDA) 23, 32

National Longitudinal Alcohol Epidemiological 

Survey (NLAES) 23, 27

National Osteoporosis Foundation 250, 312, 419

National Pregnancy and Health Survey 24

National Science Foundation (NSF) 191, 236–37,

394–95

National Women’s Health Network 1, 401, 459

Navajo Research Program 219

nephropathy, analgesic 173–75, 178, 180

nicotine replacement therapy 239, 451

nicotine withdrawal 29

NIH Consensus Development Conference on Optimal

Calcium Intake 47

NIH Revitalization Act of 1991-1992 9

NIH Revitalization Act of 1993 3, 215

nonsteroidal anti-inflammatory drugs (NSAIDS) 84, 89

North Shore University Hospital 189

Nurses Study 38, 389

nursing home admissions 44

nutrition

and diabetes 12

and eating disorders 55, 122, 346

supplementation 12, 169, 360

O

obesity

cardiovascular implications of 76, 78

obsessive-compulsive disorder 117

Office of Behavioral and Social Science Research, 

NIH 35

Office of Extramural Research, NIH 4

Office of Medical Applications of Research, NIH 232

Office of Protection from Research Risks, NIH 10, 215

Office of Research on Women’s Health, NIH iii, v–vi,

x–xi, xiii, xvii, 1–2, 7–8, 37, 73, 187, 215, 224,

245–246, 248, 250, 253, 259, 307, 316, 320, 

332, 334, 342, 353, 368, 375, 377, 411, 414,

429, 457, 467

Office of Science Education, NIH 5, 188

Office of Women’s Health, PHS 5

older women – drug and alcohol effects 444

oral contraceptives (see birth control)

oral health 41, 135–38, 140, 142, 316–17, 

393–95, 466

orthopaedics 48, 52, 57

osteoarthritis 43, 47, 49, 391, 421, 446–47, 463–64

osteoporosis

osteoporotic fractures 12, 51–52, 57, 312,

419–20

Osteoporotic Fractures, Study of 48

ovarian failure, premature 170, 172

oversampling (see also diversity and minority 

groups) 27

P

pain 12, 16, 20, 31, 43, 47–49, 51, 54, 56–57, 71, 

83, 88–91, 119, 125–26, 129–31, 133, 136, 138,

140–41, 143–45, 169, 177, 248, 267, 276, 310,

316, 350, 365, 376, 387, 393, 404, 412–13, 425,

427, 433, 448–49, 454–56, 464, 469

Pan American Health Organization 37

panic attacks 117

parasitic diseases 12
550

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

Parkinson’s disease 125

pay equity, and women scientists 188

pediatric AIDS (see AIDS, pediatric)

pelvic floor dysfunction/relaxation 81, 169–70, 

172, 174, 176, 179, 181–83, 432

pelvic inflammatory disease (PID) 102, 417, 431

pelvic pain 84, 169–70, 172, 417

pelvic prolapse 431

peptic ulcer disease

and NSAIDS 84, 469

perimenopause 50, 445

periodontal disease

in pregnant women 142

as risk factor for myocardial infarction 

and stroke 139

pharmacodynamics (PD) 120, 147–51, 155–56,

158–62, 208, 210, 235, 354, 443

pharmacogenetics 150, 156, 159, 161

pharmacokinetics (PK) 31, 147–51, 154–62, 170,

208, 210, 235, 315, 354

phobias 26, 112, 116–17

physical activity (see also exercise)

12, 40, 43, 46–48, 51–52, 54–58, 79, 96, 201,

336, 361–62, 391, 409, 415, 428, 433, 439, 

441, 450, 458

Physician Health Study 273

phytoestrogens 64

polycystic ovarian syndrome 170, 172, 440

polymerase chain reaction (PCR) 94, 103

posttraumatic stress disorder (PTSD) 26–27, 116

Postmenopausal Estrogen/Progesterone Intervention

(PEPI) Trial 3, 11, 38, 148, 27

postmenopausal women 11–12, 23, 25, 28–29, 

127, 148, 150, 158–59, 161, 209, 273, 313, 

321, 369, 400, 429, 444–45

poverty – and mental disorders 410–11

pre-symptomatic testing 258–59

preeclampsia 169, 171, 175, 178, 327

pregnancy

dialysis 174

digestive diseases during 81

drug use 238

ectopic 168–69, 171, 248, 431

kidney disorders 173, 182

mental disorders 122

normal 130, 168, 175, 178, 180

periodontal disease 142

renal complications 174–75, 178, 180

unintended 249, 315, 319–21, 350, 417

premenstrual syndrome (PMS) 168, 170, 172, 287

preterm birth 142, 347–48

prevention

of infection 160

intervention 26, 56, 62, 69–70, 123, 281, 409

research 31, 52, 54, 57, 60, 62, 64–67, 69–70,

106, 122–23, 130, 233, 249, 292, 318, 333,

390, 425, 428, 446, 449, 469–70

primary biliary cirrhosis (PBC) 84–86, 88, 

415–16, 469

Prostate, Lung, Colon, and Ovarian Cancer 

Screening Trial 63

psychiatric disorders – comorbid, in opiate and 

cocaine abusers; and drug abuse 24, 26, 28, 

30, 121

psychosocial issues 399, 440

psychotherapy 114, 118

Public Health Service (PHS) iii, xiv, 1, 3–5, 7, 9, 

11, 203, 225, 232, 481, 494, 507, 511, 523, 

536, 538

pulmonary disease, chronic 347, 391

R

raloxifene 64

rape 116, 120

Re-entry Program for Biomedical Scientists 

5, 186, 194

recruiting and retaining women in clinical trials 207

reflex sympathetic dystrophy 138

renal disease, end-stage 173–75, 177, 179, 182

repetitive strain injuries 429

repetitive stress syndrome 54, 391, 429

reproductive health problems – and AOD use 28

reproductive physiology 28, 31

resiliency – and mental disorders 121

Reye’s syndrome 87

rheumatic heart disease 74

rheumatoid arthritis (RA) 43, 51, 53, 93, 97–99, 

109, 209, 260, 320, 322, 421, 437, 450, 457,

463–64

Routine Antenatal Diagnostic Imaging Ultrasound

Study (RADIUS) 232

rural women 69, 123, 338, 397
551

VOLUME 2

S

sarcopenia 51

schizophrenia 112, 122–25, 128

scleroderma 93, 97–99, 320, 322, 342, 463–64

scoliosis 54, 407, 425

seasonal affective disorder (SAD) 113

selective estrogen receptor molecules 50

selective estrogen receptor modulators 148

self confidence – and mental disorders 114, 359

self esteem – and mental disorders 114, 372

sex differences (see also gender differences) 

16–17, 19, 34, 125–30, 132, 190, 239, 451

sexism in medicine 189

sexual abuse

and alcohol and drug use 27, 29, 32

childhood 29, 32, 120

and irritable bowel syndrome 81

sexual assault 26, 29, 116, 120, 399–400, 417

sexual behavior, risky 29

sexual dimorphism 11, 96, 127, 130, 314

sexual disorders 350

sexual orientation 27, 31–32, 112, 121, 192, 325,

398–99

sexually transmitted diseases (STD) 32, 93–94, 101,

106, 108–10, 120, 168, 170–72, 203, 233,

248–49, 313, 316, 318, 321, 325, 339, 348, 

350, 353, 378, 398, 404, 409–10, 417, 475

silicone breast implants 396

Sjögren’s syndrome 93, 98–99, 137, 141, 322–23,

342, 413

sleep apnea 128

sleep disorders 128, 418

smoking

adolescents 24, 62, 293

African-American women 328

cancer 60–62, 67, 70, 135, 283, 424–25

cerebrovascular disease 24

cessation 12, 62, 69–70, 218, 239, 394, 445, 451

coronary artery disease 24, 336

early menopause 24

Hispanic women 24

prevalence 24, 61

rates among adolescents 24

rates among women 24

weight control 61

Society for the Advancement of Women’s Health

Research 206, 427

Society of Gynecologic Oncologists 66, 407, 414

socioeconomic status (SES) 6–7, 23, 27, 31–32,

35–36, 39, 49, 56, 59, 61, 99, 121, 205, 216–17,

316, 318, 329, 379, 447

special populations (see also minority groups)

7, 13, 32, 99, 123, 193, 195, 199, 202, 302, 308

spermicides 168

sports injuries 46, 55, 58, 332, 391, 428, 467

steatohepatitis, nonalcoholic 85–86, 88

steroid hormones 71, 97, 99, 124, 126, 150

strategic management 326

strep, Group B 109

stress

fractures 46, 51–52, 57, 428

and periodontal disease 316–17

stroke 51, 73–75, 77, 119, 125, 127–29, 132, 139,

174, 242, 272, 274, 313, 317–18, 328, 334, 

339, 391, 410, 428, 474

substance abuse (see also drug abuse or alcohol abuse)

24–25, 28–29, 31, 34, 114, 214, 221, 245, 325,

337, 361, 401, 411, 417–18, 470

Surveillance, Epidemiology, and End Results (SEER)

data 61

syphilis 4, 104–05, 107, 319, 378

systemic lupus erythematosus 93, 97–99, 173–74,

421, 463

Systolic Hypertension in the Elderly Trial 275

T

tamoxifen 60, 64–65, 69, 159, 359

Tay-Sachs 271

technology transfer 232, 386

temporomandibular disorders 137–38, 393

tenure – of women faculty 193, 333, 370

Thailand prostitute study 103

thalidomide 4

therapeutic agents, identification of risks 234

Title VII Allied Health Project Grant Program 324

Title X 321

torsades de pointes, drug-related 234

torticollis 128, 132

toxemia 76

toxins, chemical 434

transportation 195, 202, 218–19, 288, 397, 402
552

A GENDA FOR R ESEARCH ON W OMEN ’ S H EALTH FOR THE 2 1 S T C ENTURY

treatment

barriers 30–31, 203

exposure treatment 116

methodologies, for women alcoholics 26

trichimonas vaginalis (T. Vag) 105, 108

trichomoniasis 319

trigeminal neuralgia 138, 393

tuberculosis 12, 109, 288, 410

Tulane University 217

Turner’s syndrome 126

U

universal health care 268

University of New Mexico 200, 460

University of Wisconsin 219, 365

urinary tract infections (UTIs) 109, 174, 176, 

179, 181, 183, 339, 417, 453–54

uterine bleeding 170, 172, 475

V

vaginal yeast infections 104

victimization

crime, and drug abuse 29, 32

long-term effects 26

violence

childhood, and use of AOD 29, 32

domestic 116, 120, 140, 208, 225, 364, 376–77,

397, 417–18, 428

long-term effects 26, 120

and mental disorders 113, 120

W

welfare-to-work 37

Women Scientist Advisory Committee 188

Women’s Health Initiative (WHI) 10–12, 38, 48, 138,

148, 245–46, 248, 274, 313, 322, 326–27, 342,

363, 370, 389, 430–31

Women’s Health Study, NHLBI 273, 277–78

World Bank 37, 111, 115

World Health Organization 35, 41, 45, 210, 329

X

Xavier University 217
Agenda for Research on Women’s Health for the 21st Century is a 6-volume report from four scientific meetings 

and public hearings to establish an agenda for women’s health research for the 21st century. Volume 1 contains the executive summary and volume 2 is a composite report containing recommendations from all four

meetings. Volume 3 contains public testimony from the Bethesda, Maryland meeting, and volumes 4, 5, and 6 are

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 Volume 1 — Agenda for Research on Women’s Health for the 21st Century, A Report of the Task Force on the NIH

Women’s Health Research Agenda for the 21st Century, Executive Summary; NIH Publication No. 99-4385.

 Volume 2 — Agenda for Research on Women’s Health for the 21st Century, A Report of the Task Force on the NIH

Women’s Health Research Agenda for the 21st Century; NIH Publication No. 99-4386.

 Volume 3 — Agenda for Research on Women’s Health for the 21st Century, Public Testimony; Bethesda, Maryland:

November 1997; NIH Publication No. 99-4387.

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Philadelphia Scientific Meeting and Public Hearing, September 1996; NIH Publication No. 99-4388.

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